Jada™ System JADA-1001Recalls & reported problems

Summary

The FDA's MAUDE database contains 207 adverse event reports that list this exact device (DI 00850017882003), received between Mar 12, 2021 and Aug 5, 2025 — classified as 166 injuries, 41 malfunctions.

The most frequently reported specific device problem is “Improper or Incorrect Procedure or Method” (11 reports).

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 25 most recent of 207 reports, in the reporter's own words as published by the FDA.

• InjuryAug 5, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A CT SCAN REVEALED A UTERINE RUPTURE [UTERINE RUPTURE]. THE PATIENT REPORTED ABDOMINAL AND SHOULDER PAIN DURING AND AFTER THE USE OF THE JADA. [ABDOMINAL PAIN]. THE PATIENT REPORTED ABDOMINAL AND SHOULDER PAIN DURING AND AFTER THE USE OF THE JADA. [ARTHRALGIA]. CASE NARRATIVE: THIS SPONTANEOUS REPORT ORIGINATING FROM UNITED STATES WAS RECEIVED FROM A NURSING DIRECTOR (ALSO REPORTED AS HOSPITAL ADMINISTRATOR) REFERRING TO A FEMALE PATIENT OF AN UNKNOWN AGE VIA CLINICAL ACCOUNT SPECIALIST (CAS). THE PATIENT'S MEDICAL HISTORY INCLUDED PREGNANCY AND DELIVERY. THE PATIENT'S CONCURRENT CONDITIONS, DRUG REACTIONS OR ALLERGIES AND CONCOMITANT MEDICATIONS WERE NOT REPORTED. THIS REPORT CONCERNS 1 PATIENT(S) AND 1 DEVICE(S). ON AN UNKNOWN DATE, THE PATIENT WAS PLACED WITH VACUUM-INDUCED HEMORRHAGE CONTROL SYSTEM (JADA SYSTEM) VIA INTRAUTERINE ROUTE (LOT # AND EXPIRATION DATE WERE NOT REPORTED) FOR POSTPARTUM HEMORRHAGE. THE PATIENT HAD ABDOMINAL AND SHOULDER PAIN (ABDOMINAL PAIN) (ARTHRALGIA) DURING AND AFTER THE USE OF THE VACUUM-INDUCED HEMORRHAGE CONTROL SYSTEM (JADA SYSTEM). THE COMPUTED TOMOGRAPHY (CT) SCAN REVEALED A UTERINE RUPTURE. THE RUPTURE REQUIRED SURGICAL REPAIR. THE PATIENT WA

  Patient problems: Abdominal Pain; Arthralgia; Insufficient Information

  MAUDE report 22719028 ↗
• InjuryJul 30, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  FOLLOW-UP INFORMATION HAS BEEN RECEIVED FROM NURSING DIRECTOR (ALSO REPORTED AS HOSPITAL ADMINISTRATOR) ON 29-JUL-2025. THE PATIENT GAVE A LIVE BIRTH VIA C-SECTION DELIVERY IN THE PAST. THE PATIENT'S CURRENT PREGNANCY TYPE WAS SINGLETON PREGNANCY. THE PATIENT WAS HAVING A TRIAL OF LABOR AFTER C-SECTION AND WAS ABLE TO DELIVER VAGINALLY. THE PATIENT WAS TREATED WITH UTEROTONIC AGENTS PER THE FACILITY POSTPARTUM HEMORRHAGE PROTOCOL AND NO OTHER DEVICES WERE USED PRIOR TO THE USE OF VACUUM-INDUCED HEMORRHAGE CONTROL SYSTEM (JADA SYSTEM). THE BLEEDING WAS CONTROLLED WITH THE VACUUM-INDUCED HEMORRHAGE CONTROL SYSTEM (JADA SYSTEM). THE VACUUM-INDUCED HEMORRHAGE CONTROL SYSTEM (JADA SYSTEM) WAS REMOVED BUT THE PATIENT CONTINUED TO HAVE CONCERNED PAIN AND LABS. THE PATIENT WAS TAKEN TO THE OPERATING ROOM FOR REPAIR OF THE UTERINE RUPTURE. THE PATIENT RECEIVED 1 OR 2 UNITS OF BLOOD. ON AN UNKNOWN DATE IN 2025, PATIENT RECOVERED FROM UTERINE RUPTURE AND ABDOMINAL PAIN. THE OUTCOME OF ARTHRALGIA WAS UNKNOWN. THE PATIENT WAS DISCHARGED HOME AND LENGTH OF HOSPITAL STAY WAS NOT REPORTED. THE FACILITY PERFORMED A CASE REVIEW RECENTLY AND THAT OUTCOME WAS THAT THE VACUUM-INDUCED HEMORRHAGE CONTROL

  Patient problems: Abdominal Pain; Arthralgia; Insufficient Information; Uterine Perforation

  MAUDE report 22667635 ↗
• InjuryMar 19, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  POSTERIOR UTERINE RUPTURE [UTERINE RUPTURE]. CASE NARRATIVE: THIS SPONTANEOUS REPORT ORIGINATING FROM UNITED STATES WAS RECEIVED FROM OTHER HEALTH PROFESSIONAL (RISK MANAGER) REFERRING TO A 35-YEAR-OLD FEMALE PATIENT VIA FOOD AND DRUG ADMINISTRATION (FDA). THE PATIENT HAD CESAREAN SECTION DELIVERY. THE PATIENT'S CONCURRENT CONDITION INCLUDED HYPOTENSION. THE PATIENT¿S CONCOMITANT MEDICATIONS AND PAST DRUG REACTIONS/ALLERGIES WERE NOT REPORTED. THIS REPORT CONCERNS 1 PATIENT(S) AND 1 DEVICE(S). ON (B)(6) 2022, THE PATIENT WAS PLACED WITH VACUUM-INDUCED HEMORRHAGE CONTROL SYSTEM (JADA SYSTEM) 1.0 VIA INTRAVAGINAL ROUTE (DEFAULTED) (LOT #, SERIAL # AND EXPIRATION DATE WERE NOT REPORTED) FOR POST-PARTUM HEMORRHAGE. ON (B)(6) 2022, THE VACUUM-INDUCED HEMORRHAGE CONTROL SYSTEM (JADA SYSTEM) PLACED, AND THE PATIENT STABILIZED. PATIENT TRANSFERRED TO SURGICAL INTENSIVE UNIT (SICU) SUBSEQUENTLY WITH NEED FOR RETURN TO SURGERY. THE PATIENT WITH A SUPRACERVICAL HYSTERECTOMY AFTER FINDING POSTERIOR UTERINE RUPTURE (UTERINE RUPTURE). IT WAS UNSURE IF VACUUM-INDUCED HEMORRHAGE CONTROL SYSTEM (JADA SYSTEM) INVOLVED IN COMPLICATION. EVENT CAUSED PROLONGED HOSPITALIZATION. THE OUTCOME OF EVENT UTER

  Patient problems: Rupture

  MAUDE report 21641332 ↗
• InjuryFeb 6, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT HAVE A CERVICAL LACERATION [UTERINE CERVICAL LACERATION]. CASE NARRATIVE: THIS SPONTANEOUS HEARSAY REPORT ORIGINATING FROM UNITED STATES WAS RECEIVED FROM A PHYSICIAN, REFERRING TO A FEMALE PATIENT OF UNKNOWN AGE VIA CLINICAL ACCOUNT SPECIALIST (CAS). THE PATIENT'S MEDICAL HISTORY, CONCURRENT CONDITIONS, DRUG REACTIONS OR ALLERGIES AND CONCOMITANT MEDICATIONS WERE NOT REPORTED. THIS REPORT CONCERNS 1 PATIENT(S) AND 1 DEVICE(S). ON AN UNKNOWN DATE, THE PATIENT WAS PLACED WITH VACUUM-INDUCED HEMORRHAGE CONTROL SYSTEM (JADA SYSTEM) 1001 VIA VAGINAL ROUTE (DEFAULTED) (LOT #, SERIAL # AND EXPIRATION DATE WERE NOT REPORTED) FOR AN UNKNOWN INDICATION. ON AN UNKNOWN DATE, THE PATIENT HAD A CERVICAL LACERATION (UTERINE CERVICAL LACERATION), WHICH THE HEALTHCARE PROVIDER (HCP) DID NOT BELIEVE WAS PRESENT PRIOR TO VACUUM-INDUCED HEMORRHAGE CONTROL SYSTEM (JADA SYSTEM) PLACEMENT. THE PHYSICIAN WHO REPORTED THE EVENT WAS NOT THE HEALTHCARE PROFESSIONAL OF THIS DEVICE BUT HEARD ABOUT THE EVENT SECONDHAND. NO PRODUCT COULD BE OBTAINED. THE OUTCOME OF THE EVENT UTERINE CERVICAL LACERATION WAS UNKNOWN. THE REPORTER¿S CAUSALITY ASSESSMENT WAS NOT REPORTED. FOLLOW-UP INFORMATION HAS BEEN RECE

  Patient problems: Laceration(s)

  MAUDE report 21321125 ↗
• InjuryJan 21, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT WAS STILL CONTINUED TO BLEED [DEVICE INEFFECTIVE] THE SECOND JADA WAS REMOVED, AND THEY NOTICED THE UTERINE WAS STILL PARTIALLY INVERTED [CONTRAINDICATED DEVICE USED] NO ADDITIONAL AE REPORTED [NO ADVERSE EVENT]. CASE NARRATIVE: THIS SPONTANEOUS REPORT ORIGINATING FROM UNITED STATES WAS RECEIVED FROM A NURSE REFERRING TO A FEMALE PATIENT OF UNKNOWN AGE VIA CLINICAL ACCOUNT SPECIALIST (CAS). THE PATIENT'S MEDICAL HISTORY, CONCOMITANT MEDICATIONS AND PAST DRUG REACTIONS/ALLERGIES WERE NOT REPORTED. THE PATIENT'S CONCURRENT CONDITION INCLUDED UTERINE INVERSION. THIS REPORT CONCERNS 1 PATIENT(S) AND 1 DEVICE(S). ON AN UNKNOWN DATE IN 2024 (ALSO REPORTED AS COUPLE OF MONTHS AGO), THE PATIENT WAS PLACED WITH VACUUM-INDUCED HEMORRHAGE CONTROL SYSTEM (JADA SYSTEM) 1001 VIA VAGINAL ROUTE (LOT/SERIAL# NUMBER AND EXPIRATION DATE WERE NOT REPORTED) FOR POSTPARTUM HEMORRHAGE. THE VACUUM-INDUCED HEMORRHAGE CONTROL SYSTEM (JADA SYSTEM) WAS USED, AND THE PATIENT CONTINUED TO BLEED SO THE NURSE WAS CONCERNED. THEY REMOVED THE VACUUM-INDUCED HEMORRHAGE CONTROL SYSTEM (JADA SYSTEM) AND APPEARED THE INVERSION HAD NOT BEEN COMPLETELY RESOLVED SO THEY WENT AHEAD AND RESOLVED IT AGAIN AND USE

  Patient problems: Hemorrhage/Blood Loss/Bleeding; Insufficient Information; No Clinical Signs, Symptoms or Conditions

  MAUDE report 21196048 ↗
• InjuryJan 21, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE JADA WAS USED, AND SHE CONTINUED TO BLEED SO THEY WERE CONCERNED [DEVICE INEFFECTIVE] THEY REMOVED THE JADA AND APPEARED THE INVERSION HAD NOT BEEN COMPLETELY RESOLVED [CONTRAINDICATED DEVICE USED] NO ADDITIONAL AE REPORTED [NO ADVERSE EVENT]. CASE NARRATIVE: THIS SPONTANEOUS REPORT ORIGINATING FROM UNITED STATES WAS RECEIVED FROM A NURSE REFERRING TO A FEMALE PATIENT OF UNKNOWN AGE VIA CLINICAL ACCOUNT SPECIALIST (CAS). THE PATIENT'S MEDICAL HISTORY, CONCOMITANT MEDICATIONS AND PAST DRUG REACTIONS/ALLERGIES WERE NOT REPORTED. THE PATIENT'S CONCURRENT CONDITION INCLUDED UTERINE INVERSION. THIS REPORT CONCERNS 1 PATIENT(S) AND 1 DEVICE(S). ON AN UNKNOWN DATE IN 2024 (ALSO REPORTED AS COUPLE OF MONTHS AGO), THE PATIENT WAS PLACED WITH VACUUM-INDUCED HEMORRHAGE CONTROL SYSTEM (JADA SYSTEM) VIA VAGINAL ROUTE (LOT #, SERIAL # AND EXPIRATION DATE WERE NOT REPORTED) FOR POSTPARTUM HEMORRHAGE. THE VACUUM-INDUCED HEMORRHAGE CONTROL SYSTEM (JADA SYSTEM) WAS USED, AND THE PATIENT CONTINUED TO BLEED (DEVICE INEFFECTIVE) SO THE NURSE WAS CONCERNED. THEY REMOVED THE VACUUM-INDUCED HEMORRHAGE CONTROL SYSTEM (JADA SYSTEM) AND APPEARED THE INVERSION HAD NOT BEEN COMPLETELY RESOLVED (CONTRAINDIC

  Patient problems: Hemorrhage/Blood Loss/Bleeding; Insufficient Information; No Clinical Signs, Symptoms or Conditions

  MAUDE report 21196047 ↗
• MalfunctionDec 3, 2024Break; Fracture; Material Integrity Problem; Break; Fracture; Material Integrity Problem

  THE SEAL HAD RUPTURED AND THE JADA SYSTEM EXPELLED [DEVICE EXPULSION] AND REALIZED THE SEAL HAD RUPTURED AND THE JADA SYSTEM EXPELLED [DEVICE BREAKAGE] THEN MOVED THE PATIENT FROM ONE BED TO ANOTHER AND REALIZED THE SEAL HAD RUPTURED [DEVICE USE ISSUE], NO ADDITIONAL AE/PQC REPORTED [NO ADVERSE EVENT]. CASE NARRATIVE: THIS SPONTANEOUS REPORT ORIGINATING FROM UNITED STATES WAS RECEIVED FROM A REGISTERED NURSE REFERRING TO A FEMALE PATIENT OF UNKNOWN AGE VIA CLINICAL ACCOUNT SPECIALIST (CAS). THE PATIENT¿S MEDICAL HISTORY, CURRENT CONDITIONS, CONCOMITANT MEDICATIONS AND PAST DRUG REACTIONS/ALLERGIES WERE NOT REPORTED. THIS REPORT CONCERNS 1 PATIENT(S) AND 1 DEVICE(S). ON AN UNKNOWN DATE, THE PATIENT WAS PLACED WITH VACUUM-INDUCED HEMORRHAGE CONTROL SYSTEM (JADA SYSTEM) 1001 VIA INTRAVAGINAL ROUTE (DEFAULTED) (LOT#, SERIAL # AND EXPIRATION DATE WERE NOT REPORTED) FOR AN UNKNOWN INDICATION. AFTER INSERTING THE VACUUM-INDUCED HEMORRHAGE CONTROL SYSTEM (JADA SYSTEM), THE NURSE INJECTED A TOTAL OF 120 MILLILITERS OF STERILE FLUID INTO THE CERVICAL SEAL. THEN THE PATIENT WAS MOVED FROM ONE BED TO ANOTHER (DEVICE USE ISSUE) AND REALIZED THE SEAL HAD RUPTURED (DEVICE BREAKAGE) AND THE VACUUM

  Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions

  MAUDE report 20830930 ↗
• InjuryOct 25, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE JADA DID NOT CONTROL THE BLEEDING [DEVICE INEFFECTIVE]. NO ADDITIONAL AE/PQC REPORTED. NO FURTHER INFORMATION PROVIDED. [NO ADVERSE EVENT]. CASE NARRATIVE: THIS SPONTANEOUS REPORT ORIGINATING FROM UNITED STATES WAS RECEIVED FROM PHYSICIAN REFERRING TO A FEMALE PATIENT OF UNKNOWN AGE VIA CLINICAL EDUCATOR. THIS WAS THE PATIENT¿S FIRST BABY (SINGLETON PREGNANCY). THE PATIENT¿S WATER BROKE, AND DURING LABOR, THERE WERE NO RISK FACTORS FOR HEMORRHAGE. A 38.6 WEEK BABY WAS DELIVERED VAGINALLY. THE DELIVERY WAS NOT INDUCED. THE PATIENT DEVELOPED A VAGINAL LACERATION AND LOST 1600 CC OF BLOOD PRIOR TO THE INITIATION OF THE VACUUM-INDUCED HEMORRHAGE CONTROL SYSTEM (JADA SYSTEM). THE PATIENT WAS DIAGNOSED WITH A VAGINAL LACERATION, NOT ENDOMETRITIS (INFECTION OF THE UTERUS). THE PATIENT DID NOT HAVE A HISTORY OF ABNORMAL POSTPARTUM UTERINE BLEEDING OR HEMORRHAGE. NO INTERVENTIONS WERE GIVEN PRIOR TO THE USE OF VACUUM-INDUCED HEMORRHAGE CONTROL SYSTEM (JADA SYSTEM). THE PATIENT¿S CONCOMITANT MEDICATIONS AND PAST DRUG REACTIONS/ALLERGIES WERE NOT REPORTED. THIS REPORT CONCERNS 1 PATIENT(S) AND 1 DEVICE(S). ON AN UNKNOWN DATE, THE PATIENT WAS PLACED WITH VACUUM-INDUCED HEMORRHAGE CONTROL S

  Patient problems: Hemorrhage/Blood Loss/Bleeding; No Clinical Signs, Symptoms or Conditions

  MAUDE report 20533585 ↗
• MalfunctionMar 6, 2024Component Incompatible; Defective Device; Component or Accessory Incompatibility; Compatibility Problem; Component Incompatible; Defective Device; Component or Accessory Incompatibility; Compatibility Problem

  COULDN'T GET THE AIR OUT OF THE CERVICAL SEAL [DEVICE DEFECTIVE], NO ADDITIONAL AE REPORTED, NO PQC REPORTED. [NO ADVERSE EVENT] . CASE NARRATIVE: THIS SPONTANEOUS REPORT ORIGINATING FROM UNITED STATES WAS RECEIVED FROM A PHYSICIAN VIA CLINICAL ACCOUNT SPECIALIST (CAS) REFERRING TO A FEMALE PATIENT OF UNKNOWN AGE. THE PATIENT'S MEDICAL HISTORY, PAST DRUGS OR ALLERGIES, AND CONCOMITANT MEDICATIONS WERE NOT REPORTED. THIS REPORT CONCERNS 1 PATIENT(S) AND 1 DEVICE(S). APPROXIMATELY IN (B)(6) 2024 (REPORTED AS SOMETIME LAST WEEK), THE PATIENT UNDERWENT INSERTION WITH VACUUM-INDUCED HEMORRHAGE CONTROL SYSTEM (JADA SYSTEM) (LOT # AND EXPIRATION DATE WERE NOT REPORTED) VIA VAGINAL ROUTE FOR AN UNKNOWN INDICATION. APPROXIMATELY IN (B)(6) 2024 (REPORTED AS SOMETIME LAST WEEK), THE PHYSICIAN PUT THE LUER-LOCK SYRINGE IN TO DEFLATE THE VACUUM-INDUCED HEMORRHAGE CONTROL SYSTEM (JADA SYSTEM) AND COULD NOT GET THE AIR OUT OF THE CERVICAL SEAL (DEVICE DEFECTIVE). THE PHYSICIAN OBTAINED A SECOND VACUUM-INDUCED HEMORRHAGE CONTROL SYSTEM (JADA SYSTEM) TO USE, AND IT WORKED JUST FINE. THE PHYSICIAN TOLD STAFF TO SET THE DEFECTIVE VACUUM-INDUCED HEMORRHAGE CONTROL SYSTEM (JADA SYSTEM) ASIDE, BUT THEY

  Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions

  MAUDE report 18845946 ↗
• MalfunctionFeb 29, 2024Leak/Splash; Mechanical Problem; Leak/Splash; Mechanical Problem

  ¿WE AREN¿T SURE IF THERE WAS A CHARTING ERROR OR A LEAK IN THE SEAL. THE CHARTING SAYS 120 CCS WERE PLACED IN THE SEAL, BUT WHEN REMOVED THERE WAS ONLY 50 CCS ABLE TO BE REMOVED [CIRCUMSTANCE OR INFORMATION CAPABLE OF LEADING TO DEVICE USE ERROR] NO ADDITIONAL AE REPORTED, NO PQC REPORTED. [NO ADVERSE EVENT] CASE NARRATIVE: THIS SPONTANEOUS REPORT ORIGINATING FROM UNITED STATES WAS RECEIVED FROM OTHER HEALTH PROFESSIONAL (NURSE) VIA DESIGNATED POINT OF CONTACT (DPOC) REFERRING TO A FEMALE PATIENT OF UNKNOWN AGE. THE PATIENT'S MEDICAL HISTORY, PAST DRUGS OR ALLERGIES, AND CONCOMITANT MEDICATIONS WERE NOT REPORTED. THIS REPORT CONCERNS 1 PATIENT(S) AND 1 DEVICE(S). ON 02-JAN-2024, THE PATIENT WAS PLACED WITH THE VACUUM-INDUCED HEMORRHAGE CONTROL SYSTEM (JADA SYSTEM) VIA DEFAULTED TO VAGINAL ROUTE (BATCH/LOT# AND EXPIRY DATE WERE NOT REPORTED) FOR AN UNKNOWN INDICATION. ON 02-JAN-2024, IT WAS REPORTED THAT THE CHARTING SAID 120 CUBIC CENTIMETERS (CCS) WERE PLACED IN THE SEAL, BUT WHEN REMOVED THERE WAS ONLY 50 CCS ABLE TO BE REMOVED. THE HEALTH CARE PROFESSIONAL (HCP) WAS NOT SURE IF THERE WAS A CHARTING ERROR OR A LEAK IN THE SEAL (CIRCUMSTANCE OR INFORMATION CAPABLE OF LEADING TO DE

  Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions

  MAUDE report 18807521 ↗
• InjuryNov 16, 2023Break; Fracture; Material Integrity Problem; Break; Fracture; Material Integrity Problem

  THEY COULD NOT GET ANY SUCTION BECAUSE IT WASN'T HOLDING A SEAL BECAUSE THERE WERE PINPOINT HOLES IN THE DEVICE [DEVICE MALFUNCTION]. MULTIPLE SMALL PUNCTURE HOLES IN THE CERVICAL SEAL THAT WAS LEAKING FLUID. [DEVICE PHYSICAL PROPERTY ISSUE]. MULTIPLE SMALL PUNCTURE HOLES IN THE CERVICAL SEAL THAT WAS LEAKING FLUID [POOR QUALITY DEVICE USED]. CASE NARRATIVE: THIS SPONTANEOUS REPORT ORIGINATING FROM UNITED STATES WAS RECEIVED FROM A NURSE MANAGER VIA EMAIL REFERRING TO A FEMALE PATIENT OF UNKNOWN AGE. PATIENT'S CURRENT CONDITIONS, CONCOMITANT MEDICATIONS AND PAST DRUG REACTIONS/ALLERGIES WERE NOT REPORTED. THIS REPORT CONCERNS 1 PATIENT(S) AND 1 DEVICE. ON UNKNOWN DATE, THE PATIENT UNDERWENT INSERTION WITH VACUUM-INDUCED HEMORRHAGE CONTROL SYSTEM (JADA SYSTEM) VIA INTRAVAGINAL ROUTE (LOT #, SERIAL # AND EXPIRATION DATE WERE NOT REPORTED) FOR UNKNOWN INDICATION. ON (B)(6) 2023, THE NURSE MANAGER STATED THAT THEY HAD A DEFECTIVE DEVICE, THEY NOTED MULTIPLE SMALL PUNCTURE HOLES IN THE CERVICAL SEAL THAT WAS LEAKING FLUID ((POOR QUALITY DEVICE USED) AND (DEVICE PHYSICAL PROPERTY ISSUE). NURSE STATED IT APPEARS THE STAFF USED THE DEVICE ON THE PATIENT, AS THERE WAS BLOOD ON THE DEVICE IN

  Patient problems: Insufficient Information

  MAUDE report 18147680 ↗
• InjuryDec 15, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THIS INITIAL SPONTANEOUS REPORT ORIGINATING FROM THE UNITED STATES, WAS RECEIVED FROM A REGISTERED NURSE, REFERRING TO A FEMALE PATIENT OF UNKNOWN AGE. THE PATIENT'S HISTORICAL CONDITION INCLUDED CAESAREAN SECTION. THE PATIENT'S CURRENT CONDITIONS AND CONCOMITANT MEDICATIONS WERE NOT REPORTED. THIS REPORT CONCERNS 1 PATIENT AND 1 DEVICE. ON (B)(6) 2022, THE PATIENT WAS STARTED ON VACUUM-INDUCED HEMORRHAGE CONTROL SYSTEM (JADA SYSTEM) (LOT# WAS NOT REPORTED) FOR POSTPARTUM HEMORRHAGE (PPH). THE REPORTER STATED THAT THE VACUUM-INDUCED HEMORRHAGE CONTROL SYSTEM (JADA SYSTEM) WAS DIFFICULT TO PLACE (DEVICE PLACEMENT ISSUE), BECAUSE THE PATIENT HAD A CAESAREAN SECTION. THE REPORTER STATED THAT THIS WAS THE FIRST TIME THEY WERE USING THE VACUUM-INDUCED HEMORRHAGE CONTROL SYSTEM (JADA SYSTEM). THE REPORTER STATED THAT THE SUCTION TUBING OF THE VACUUM-INDUCED HEMORRHAGE CONTROL SYSTEM (JADA SYSTEM) WAS FILING UP WITH BLOOD UP TO THE CANISTER. THEY WERE TOLD BY THEIR REPRESENTATIVE THAT IF THIS OCCURRED THEN THE VACUUM-INDUCED HEMORRHAGE CONTROL SYSTEM (JADA SYSTEM) WAS NOT WORKING (DEVICE INEFFECTIVE). THEY WERE UNCLEAR OF THE TOTAL VOLUME OF BLOOD THAT WAS IN THE TUBING BUT THROUGH TRIAL

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available

  MAUDE report 15988489 ↗
• InjuryDec 15, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THIS INITIAL SPONTANEOUS REPORT ORIGINATING FROM THE UNITED STATES WAS RECEIVED FROM A MONITOR WHO OBSERVED A SPEAKER PROGRAM, VIA A COMPANY REPRESENTATIVE, REFERRING TO A FEMALE PATIENT OF UNKNOWN AGE. THE PATIENT'S CONCURRENT CONDITIONS, MEDICAL HISTORY AND PAST DRUG REACTIONS/ALLERGIES WERE NOT REPORTED. NO CONCOMITANT MEDICATIONS WERE REPORTED. THIS REPORT CONCERNS 1 PATIENT AND 1 DEVICE. ON AN UNKNOWN DATE, THE PATIENT WAS INSERTED WITH VACUUM-INDUCED HEMORRHAGE CONTROL SYSTEM ((B)(4) SYSTEM) (LOT# WAS NOT REPORTED) FOR AN UNKNOWN INDICATION (PRODUCT USED FOR UNKNOWN INDICATION). ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED VOMITING AND THE DEVICE MOVED (DEVICE DISLOCATION). IT WAS STATED THAT THE DEVICE WAS REMOVED AND REPLACED WITH BAKRI (REQUIRED INTERVENTION). THE OUTCOME OF VOMITING WAS UNKNOWN. THE CAUSALITY ASSESSMENT WAS NOT PROVIDED. THE AVAILABILITY OF THE VACUUM-INDUCED HEMORRHAGE CONTROL SYSTEM ((B)(4) SYSTEM) WAS UNKNOWN. UPON INTERNAL REVIEW, THE EVENT DEVICE DISLOCATION WAS DETERMINED TO BE MEDICALLY SIGNIFICANT. MEDICAL DEVICE REPORTING CRITERIA: SERIOUS INJURY. FDA MDR CODES: (B)(4).

  Patient problems: Vomiting

  MAUDE report 15988486 ↗
• InjuryOct 31, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THIS SPONTANEOUS REPORT WAS RECEIVED FROM A NURSE (REPORTED AS RESEARCH NURSE) VIA COMPANY REPRESENTATIVE (REPORTED AS CLINICAL EDUCATOR) REGARDING A FEMALE PATIENT OF UNKNOWN AGE. THE PATIENT'S HISTORICAL CONDITIONS CONSIDERED INCLUDED PREGNANCY, DELIVERY. THE PATIENT'S CONCOMITANT MEDICATIONS, AND DRUG REACTIONS/ALLERGIES WERE NOT REPORTED. THIS REPORT CONCERNS 1 PATIENT AND 1 DEVICE. ON AN UNKNOWN DATE, THE PATIENT UNDERWENT INSERTION PROCEDURE WITH VACUUM-INDUCED HEMORRHAGE CONTROL SYSTEM (JADA SYSTEM) VIA VAGINAL ROUTE (DEFAULTED ROUTE) (STRENGTH, LOT# AND EXPIRATION DATE WERE NOT REPORTED) FOR BAD HEMORRHAGE (POSTPARTUM HAEMORRHAGE) ALONG WITH MANY OTHER UNSPECIFIED INTERVENTIONS. ON AN UNKNOWN DATE, THE PATIENT'S UTERUS EVENTUALLY BECAME NECROTIC (UTERINE NECROSIS) AND HAD TO BE REMOVED. THE REPORTER STATED THAT SHE WAS PERFORMING ROOT CAUSE ANALYSIS ON THIS PATIENT. WHEN THE REPORTER PERFORMED FURTHER ANALYSIS TO SEE IF ANY OTHER PATIENTS HAD SIMILAR ISSUES, SHE IDENTIFIED ANOTHER 4 PATIENTS, ANOTHER 1 OF WHOM HAD A VACUUM-INDUCED HEMORRHAGE CONTROL SYSTEM (JADA SYSTEM) PLACED. NO ADDITIONAL INFORMATION WAS PROVIDED. THE OUTCOME OF THE EVENT WAS UNKNOWN. THE CAUSALITY ASSES

  Patient problems: Insufficient Information; Necrosis

  MAUDE report 15705126 ↗
• InjuryOct 31, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THIS SPONTANEOUS REPORT ORIGINATING FROM UNITED STATES WAS RECEIVED FROM A NURSE VIA COMPANY REPRESENTATIVE, REFERRING TO A FEMALE PATIENT OF UNKNOWN AGE. THE PATIENT HISTORICAL CONDITIONS INCLUDE PREGNANCY AND DELIVERY. THE PATIENT'S CONCURRENT CONDITIONS, PAST DRUGS/ALLERGIES, AND CONCOMITANT MEDICATIONS WERE NOT REPORTED. THIS REPORT CONCERNS 1 PATIENT AND 2 DEVICES. ON AN UNKNOWN DATE, THE PATIENT USED VACUUM-INDUCED HEMORRHAGE CONTROL SYSTEM (JADA SYSTEM) (#1) VIA VAGINAL ROUTE (STRENGTH, FREQUENCY, LOT# AND EXPIRATION DATE WERE NOT REPORTED) FOR POSTPARTUM HAEMORRHAGE (POST-PARTUM HEMORRHAGE). REPORTER STATED THAT THE PHYSICIAN HAD PLACED VACUUM-INDUCED HEMORRHAGE CONTROL SYSTEM (JADA SYSTEM) (#1) AND THE PATIENT CONTINUED TO HAVE SIGNIFICANT BLEEDING (DEVICE INEFFECTIVE), ESPECIALLY NOTED VAGINALLY AROUND THE CERVICAL SEAL (VAGINAL HAEMORRHAGE). THAT VACUUM-INDUCED HEMORRHAGE CONTROL SYSTEM (JADA SYSTEM) (#1) WAS REMOVED, AND ANOTHER VACUUM-INDUCED HEMORRHAGE CONTROL SYSTEM (JADA SYSTEM) (#2) WAS PLACED, WITH THE SAME ISSUE (POST-PARTUM HEMORRHAGE) AND SIGNIFICANT BLEEDING VAGINALLY AROUND THE SEAL (DEVICE INEFFECTIVE AND VAGINAL HAEMORRHAGE). BLEEDING CONTINUED, VACUUM-INDU

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 15705014 ↗
• InjuryOct 31, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THIS SPONTANEOUS REPORT WAS RECEIVED FROM A NURSE (REPORTED AS RESEARCH NURSE) VIA COMPANY REPRESENTATIVE (REPORTED AS CLINICAL EDUCATOR) REGARDING A FEMALE PATIENT OF UNKNOWN AGE. THE PATIENT'S HISTORICAL CONDITIONS CONSIDERED INCLUDED PREGNANCY, DELIVERY. THE PATIENT'S CONCOMITANT MEDICATIONS, AND DRUG REACTIONS/ALLERGIES WERE NOT REPORTED. THIS REPORT CONCERNS 1 PATIENT AND 1 DEVICE. ON AN UNKNOWN DATE, THE PATIENT UNDERWENT INSERTION PROCEDURE WITH VACUUM-INDUCED HEMORRHAGE CONTROL SYSTEM (JADA SYSTEM) VIA VAGINAL ROUTE (DEFAULTED ROUTE) (STRENGTH, LOT# AND EXPIRATION DATE WERE NOT REPORTED) FOR BAD HEMORRHAGE (POSTPARTUM HAEMORRHAGE) ALONG WITH MANY OTHER UNSPECIFIED INTERVENTIONS. ON AN UNKNOWN DATE, THE PATIENT'S UTERUS EVENTUALLY BECAME NECROTIC (UTERINE NECROSIS) AND HAD TO BE REMOVED. THE REPORTER STATED THAT SHE WAS PERFORMING ROOT CAUSE ANALYSIS ON THIS PATIENT. WHEN THE REPORTER PERFORMED FURTHER ANALYSIS TO SEE IF ANY OTHER PATIENTS HAD SIMILAR ISSUES, SHE IDENTIFIED ANOTHER 4 PATIENTS, ANOTHER 1 OF WHOM HAD A VACUUM-INDUCED HEMORRHAGE CONTROL SYSTEM (JADA SYSTEM) PLACED. NO ADDITIONAL INFORMATION WAS PROVIDED. THE OUTCOME OF THE EVENT WAS UNKNOWN. THE CAUSALITY ASSES

  Patient problems: Insufficient Information; Necrosis

  MAUDE report 15704250 ↗
• InjuryOct 19, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THIS SPONTANEOUS REPORT ORIGINATING FROM UNITED STATES WAS RECEIVED FROM A PHYSICIAN VIA MEDICAL SCIENCE LIAISON, REFERRING TO A FEMALE PATIENT OF UNKNOWN AGE. THE PATIENT HAD DELIVERED TWINS. THE PATIENT'S CONCURRENT CONDITIONS, PAST DRUGS/ALLERGIES, AND CONCOMITANT MEDICATIONS WERE NOT REPORTED. THIS REPORT CONCERNS 1 PATIENT AND 2 DEVICES. ON AN UNKNOWN DATE, THE PATIENT USED VACUUM-INDUCED HEMORRHAGE CONTROL SYSTEM (JADA SYSTEM) (#1) VIA VAGINAL ROUTE (STRENGTH, FREQUENCY, LOT# AND EXPIRATION DATE WERE NOT REPORTED) FOR POSTPARTUM HAEMORRHAGE (POST-PARTUM HEMORRHAGE). THE DEVICE FELL OUT (DEVICE EXPULSION) AND A NEW VACUUM-INDUCED HEMORRHAGE CONTROL SYSTEM (JADA SYSTEM) (#2) WAS PLACED, VIA VAGINAL ROUTE (STRENGTH, FREQUENCY, LOT# AND EXPIRATION DATE WERE NOT REPORTED) FOR POSTPARTUM HAEMORRHAGE (POST-PARTUM HEMORRHAGE), HOWEVER, THE SECOND DEVICE ALSO FELL OUT (DEVICE EXPULSION). AT THAT TIME, A BAKRI BALLOON WAS INITIATED WHICH DID NOT CONTROL BLEEDING AND AS A RESULT, THE EVENTS RESULTED IN A HYSTERECTOMY FOR THE PATIENT. THE VACUUM-INDUCED HEMORRHAGE CONTROL SYSTEM (JADA SYSTEM) DID NOT CONTROL BLEEDING (DEVICE INEFFECTIVE). IT WAS ALSO REPORTED THAT THE REPORTER HAD LIMITE

  Patient problems: Insufficient Information

  MAUDE report 15633114 ↗
• InjuryOct 6, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THIS SPONTANEOUS REPORT WAS RECEIVED FROM NURSE (ALSO REPORTED AS CLINICAL EDUCATOR) ON BEHALF OF PHYSICIAN REFERRING TO A FEMALE PATIENT OF UNKNOWN AGE. THE PATIENT'S CONCOMITANT MEDICATIONS AND PAST DRUG REACTIONS/ALLERGIES WERE NOT REPORTED. THE PATIENT'S MEDICAL HISTORY INCLUDED PREGNANCY AND HAD CESAREAN SECTION WHERE THE HYSTEROTOMY WAS CLOSED TRANSVAGINALLY. THE PATIENT'S CONCURRENT CONDITIONS INCLUDED UTERINE ATONY. THIS REPORT CONCERNS 1 PATIENT AND 1 DEVICE. ON AN UNKNOWN DATE, THE PATIENT HAD INSERTION WITH VACUUM-INDUCED HEMORRHAGE CONTROL SYSTEM (JADA SYSTEM) (LOT# AND EXPIRATION DATE WERE NOT REPORTED) FOR BLEEDING (POSTPARTUM HAEMORRHAGE) (DISCREPANT INFORMATION: INDICATION ALSO REPORTED AS UTERINE ATONY). IT WAS REPORTED THAT VACUUM-INDUCED HEMORRHAGE CONTROL SYSTEM (JADA SYSTEM) STOPPED BLEEDING ASSOCIATED WITH UTERINE ATONY; EXTRA STITCHES DONE TO ADDRESS BLEEDING FROM ANOTHER SOURCE (UNKNOWN BY REPORTER) (VAGINAL HAEMORRHAGE) THAT VACUUM-INDUCED HEMORRHAGE CONTROL SYSTEM (JADA SYSTEM) WOULD NOT HAVE HELPED WITH. THE VACUUM-INDUCED HEMORRHAGE CONTROL SYSTEM (JADA SYSTEM) HAD NO DEVICE ISSUE AND WORKED WITHOUT THE ISSUE. THE REPORTER STATED THAT STITCHING WAS DONE

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Hemorrhage/Blood Loss/Bleeding

  MAUDE report 15555661 ↗
• InjuryOct 6, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THIS SPONTANEOUS REPORT WAS RECEIVED FROM A COMPANY REPRESENTATIVE (CLINICAL EDUCATOR), REFERRING TO A FEMALE PATIENT OF UNKNOWN AGE. THE PATIENT'S CONCURRENT CONDITIONS, CONCOMITANT MEDICATIONS AND PAST DRUG REACTIONS/ALLERGIES WERE NOT REPORTED. THE PRIMIGRAVID PATIENT HAD A SPONTANEOUS UTERINE INVERSION, WHICH WAS CORRECTED. THIS REPORT CONCERNS 1 PATIENT AND 1 DEVICE. IT WAS REPORTED THAT ON AN UNKNOWN DATE IN (B)(6) 2022 (REPORTED AS ABOUT THREE DAYS AGO) THE PATIENT CONTINUED TO BLEED, SO VACUUM-INDUCED HEMORRHAGE CONTROL SYSTEM (JADA SYSTEM) WAS INSERTED (LOT# AND EXPIRATION DATE WERE NOT REPORTED) FOR POST-PARTUM HEMORRHAGING (POSTPARTUM HAEMORRHAGE) WITH QUICK CONTROL OF BLEEDING. THE PATIENT WAS STABLE UNTIL SHE VOMITED (VOMITING), AND THE VACUUM-INDUCED HEMORRHAGE CONTROL SYSTEM (JADA SYSTEM) WAS EXPELLED (DEVICE EXPULSION) DURING ACTIVE TREATMENT WITH SUCTION ON AT 80 MILLIMETERS OF MERCURY (MMHG). SHE BEGAN TO BLEED HEAVILY (HEAVY MENSTRUAL BLEEDING) AND WAS TAKEN TO THE OPERATION ROOM (OR), WHERE SHE WAS OPENED (REPORTED AS 'SURGICAL INTERVENTION') (REQUIRED INTERVENTION (DEVICES)) , AND IT WAS FOUND THAT HER UTERUS HAD INVERTED AGAIN (UTERINE INVERSION), WHICH WAS CO

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available

  MAUDE report 15553597 ↗
• InjurySep 29, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THIS SPONTANEOUS REPORT WAS RECEIVED FROM A REGISTERED NURSE VIA COMPANY REPRESENTATIVE REFERRING TO A FEMALE PATIENT OF UNKNOWN AGE. THE PATIENT'S HISTORICAL CONDITION INCLUDED PREGNANCY, PLACENTAL ABRUPTION, EMERGENCY CAESARIAN SECTION, STILL BIRTH AT 39 WEEKS. THIS PATIENT WAS IN DISSEMINATED INTRAVASCULAR COAGULATION (DIC) AND HAD LITTLE CLOTTING FACTORS. PATIENT'S CONCOMITANT MEDICATIONS WERE NOT REPORTED. THIS REPORT CONCERNED 1 PATIENT AND 1 DEVICE. ON AN UNKNOWN DATE, THE PATIENT'S UTERUS WAS REPAIRED, AND PATIENT UNDERWENT INSERTION PROCEDURE WITH VACUUM-INDUCED HEMORRHAGE CONTROL SYSTEM (JADA SYSTEM) (STRENGTH, ROUTE, LOT# AND EXPIRATION DATE WERE NOT REPORTED) TO STOP THE BLEEDING (POSTPARTUM HAEMORRHAGE). BLEEDING DID NOT STOP. PATIENT WAS AT 2 LITERS OF BLOOD VIA VACUUM-INDUCED HEMORRHAGE CONTROL SYSTEM (JADA SYSTEM) BEFORE SHE WENT TO INTERVENTION RADIOLOGY. VACUUM-INDUCED HEMORRHAGE CONTROL SYSTEM (JADA SYSTEM) WAS NOT GUSHING BLOOD, BUT IT WAS A SLOW TRICKLE. VACUUM-INDUCED HEMORRHAGE CONTROL SYSTEM (JADA SYSTEM) WAS TROUBLESHOT AND ROTATED THE DEVICE INTO A BETTER POSITION BECAUSE THERE WERE SUCTION ISSUES AT ONE POINT IN THE OPERATING ROOM (OR) AND THE REPORTER TH

  Patient problems: Insufficient Information

  MAUDE report 15503895 ↗
• InjurySep 28, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THIS SPONTANEOUS REPORT WAS RECEIVED FROM A NURSE MANAGER VIA CLINICAL EDUCATOR (COMPANY REPRESENTATIVE) REFERRING TO A PATIENT OF UNKNOWN AGE AND GENDER. INFORMATION REGARDING THE PATIENT'S PERTINENT MEDICAL HISTORY, CONCURRENT CONDITIONS AND CONCOMITANT MEDICATIONS WERE NOT PROVIDED. THIS REPORT CONCERNS 1 DEVICE AND 1 PATIENT. ON AN UNKNOWN DATE, THE PATIENT UNDERWENT INSERTION PROCEDURE WITH VACUUM-INDUCED HEMORRHAGE CONTROL SYSTEM (JADA SYSTEM) (STRENGTH, ROUTE OF ADMINISTRATION, LOT# AND EXPIRATION DATE WERE NOT REPORTED) FOR AN UNKNOWN INDICATION. ON AN UNKNOWN DATE, BEDSIDE NURSE DISCONTINUED THE SUCTION, BUT DID NOT DEFLATE THE CERVICAL SEAL IMMEDIATELY. THE CERVICAL SEAL WAS LEFT IN PLACE FOR ABOUT 2 HOURS AND THEN THE BEDSIDE NURSE TRIED TO FLUSH THE VACUUM-INDUCED HEMORRHAGE CONTROL SYSTEM (JADA SYSTEM) TUBE BECAUSE A CLOT FORMED IN THE VACUUM-INDUCED HEMORRHAGE CONTROL SYSTEM (JADA SYSTEM) TUBE (WRONG TECHNIQUE IN DEVICE USAGE PROCESS AND DEVICE OCCLUSION). THE DEVICE WAS REMOVED AND BLEEDING DID NOT REOCCUR. NO ADDITIONAL INFORMATION WAS PROVIDED AT THE TIME OF REPORTING. UPON INTERNAL REVIEW, THE EVENT OF WRONG TECHNIQUE IN DEVICE USAGE PROCESS AND DEVICE OCCLUSION W

  Patient problems: Insufficient Information

  MAUDE report 15495952 ↗
• InjurySep 22, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THIS SPONTANEOUS REPORT WAS RECEIVED FROM A PHYSICIAN WHO ASSISTED DURING VACUUM-INDUCED HEMORRHAGE CONTROL SYSTEM (JADA SYSTEM) USE VIA COMPANY REPRESENTATIVE (REPORTED AS CLINICAL ACCOUNT MANAGER) REFERRING TO A FEMALE PATIENT OF UNKNOWN AGE. THE PATIENT'S HISTORICAL CONDITIONS INCLUDED PREGNANCY AND CESAREAN SECTION (C/S) DELIVERY. PATIENT LOST 2200 CUBIC CENTIMETER (CC) OF BLOOD PRIOR TO VACUUM-INDUCED HEMORRHAGE CONTROL SYSTEM (JADA SYSTEM) BEING INSERTED. THE PATIENT'S CONCOMITANT MEDICATIONS, AND DRUG REACTIONS/ALLERGIES WERE NOT REPORTED. THIS REPORT CONCERNS 1 PATIENT AND 1 DEVICE. ON (B)(6) 2022, THE PATIENT UNDERWENT INSERTION PROCEDURE WITH VACUUM-INDUCED HEMORRHAGE CONTROL SYSTEM (JADA SYSTEM) (STRENGTH, ROUTE OF ADMINISTRATION, LOT# AND EXPIRATION DATE WERE NOT REPORTED) FOR POSTPARTUM HAEMORRHAGE (REPORTED AS 2200 CC OF BLOOD LOST PRIOR TO VACUUM-INDUCED HEMORRHAGE CONTROL SYSTEM (JADA SYSTEM) BEING INSERTED). PLACEMENT OF VACUUM-INDUCED HEMORRHAGE CONTROL SYSTEM (JADA SYSTEM) WAS CONFIRMED WITH ULTRASOUND. ON (B)(6) 2022 (ALSO REPORTED AS OCCURRED OVERNIGHT ON (B)(6) 2022), ONCE VACUUM-INDUCED HEMORRHAGE CONTROL SYSTEM (JADA SYSTEM) WAS PLACED, THE PATIENT CONTINUED

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available

  MAUDE report 15462677 ↗
• InjurySep 7, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THIS SPONTANEOUS REPORT WAS RECEIVED FROM A PHYSICIAN VIA CLINICAL ACCOUNT SPECIALIST (CAS) (COMPANY REPRESENTATIVE), REFERRING TO A FEMALE PATIENT OF UNKNOWN AGE. THE PATIENT'S CONCURRENT CONDITIONS, CONCOMITANT MEDICATIONS AND PAST DRUG REACTIONS/ALLERGIES WERE NOT REPORTED. THE PATIENT'S MEDICAL HISTORY INCLUDED PREGNANCY AND HAD DELIVERY. THIS REPORT CONCERNS 1 PATIENT AND 1 DEVICE. ON AN UNKNOWN DATE, THE PATIENT HAD VACUUM-INDUCED HEMORRHAGE CONTROL SYSTEM (JADA SYSTEM) INSERTION VIA VAGINAL ROUTE (LOT# AND EXPIRATION DATE WERE NOT REPORTED) BY PHYSICIAN FOR POST-PARTUM HEMORRHAGING (POSTPARTUM HAEMORRHAGE). IT WAS REPORTED THAT THERE WAS NO DEVICE ISSUE, BUT VACUUM-INDUCED HEMORRHAGE CONTROL SYSTEM (JADA SYSTEM) DID NOT CONTROL BLEEDING (DEVICE INEFFECTIVE) FOR THE PATIENT. DUE TO UNSUCCESSFUL IN CONTROLLING BLEEDING, THE PATIENT ENDED UP WITH BAKRI BALLOON. ON AN UNKNOWN DATE, THERAPY WITH VACUUM-INDUCED HEMORRHAGE CONTROL SYSTEM (JADA SYSTEM) WAS DISCONTINUED. THE PATIENT SOUGHT MEDICAL ATTENTION. IT WAS REPORTED THAT VACUUM-INDUCED HEMORRHAGE CONTROL SYSTEM (JADA SYSTEM) CAME WITH BLUE SEAL VALVE. THE PHYSICIAN STATED THAT OF THE 20 VACUUM-INDUCED HEMORRHAGE CONTROL SYSTE

  Patient problems: Insufficient Information

  MAUDE report 15374330 ↗
• InjurySep 7, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THIS SPONTANEOUS REPORT WAS RECEIVED FROM A PHYSICIAN VIA CLINICAL ACCOUNT SPECIALIST (CAS) (COMPANY REPRESENTATIVE), REFERRING TO A FEMALE PATIENT OF UNKNOWN AGE. THE PATIENT'S CONCURRENT CONDITIONS, CONCOMITANT MEDICATIONS AND PAST DRUG REACTIONS/ALLERGIES WERE NOT REPORTED. THE PATIENT'S MEDICAL HISTORY INCLUDED PREGNANCY AND HAD DELIVERY. THIS REPORT CONCERNS 1 PATIENT AND 1 DEVICE. ON AN UNKNOWN DATE, THE PATIENT HAD VACUUM-INDUCED HEMORRHAGE CONTROL SYSTEM (JADA SYSTEM) INSERTION VIA VAGINAL ROUTE (LOT# AND EXPIRATION DATE WERE NOT REPORTED) BY PHYSICIAN FOR POST-PARTUM HEMORRHAGING (POSTPARTUM HAEMORRHAGE). IT WAS REPORTED THAT THERE WAS NO DEVICE ISSUE, BUT VACUUM-INDUCED HEMORRHAGE CONTROL SYSTEM (JADA SYSTEM) DID NOT CONTROL BLEEDING (DEVICE INEFFECTIVE) FOR THE PATIENT. DUE TO UNSUCCESSFUL IN CONTROLLING BLEEDING, THE PATIENT ENDED UP WITH BAKRI BALLOON. ON AN UNKNOWN DATE, THERAPY WITH VACUUM-INDUCED HEMORRHAGE CONTROL SYSTEM (JADA SYSTEM) WAS DISCONTINUED. THE PATIENT SOUGHT MEDICAL ATTENTION. IT WAS REPORTED THAT VACUUM-INDUCED HEMORRHAGE CONTROL SYSTEM (JADA SYSTEM) CAME WITH BLUE SEAL VALVE. THE PHYSICIAN STATED THAT OF THE 20 VACUUM-INDUCED HEMORRHAGE CONTROL SYSTE

  Patient problems: Insufficient Information

  MAUDE report 15374312 ↗
• InjurySep 7, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THIS SPONTANEOUS REPORT WAS RECEIVED FROM A PHYSICIAN VIA CLINICAL ACCOUNT SPECIALIST (CAS) (COMPANY REPRESENTATIVE), REFERRING TO A FEMALE PATIENT OF UNKNOWN AGE. THE PATIENT'S CONCURRENT CONDITIONS, CONCOMITANT MEDICATIONS AND PAST DRUG REACTIONS/ALLERGIES WERE NOT REPORTED. THE PATIENT'S MEDICAL HISTORY INCLUDED PREGNANCY AND HAD DELIVERY. THIS REPORT CONCERNS 1 PATIENT AND 1 DEVICE. ON AN UNKNOWN DATE, THE PATIENT HAD VACUUM-INDUCED HEMORRHAGE CONTROL SYSTEM (JADA SYSTEM) INSERTION VIA VAGINAL ROUTE (LOT# AND EXPIRATION DATE WERE NOT REPORTED) BY PHYSICIAN FOR POST-PARTUM HEMORRHAGING (POSTPARTUM HAEMORRHAGE). IT WAS REPORTED THAT THERE WAS NO DEVICE ISSUE, BUT VACUUM-INDUCED HEMORRHAGE CONTROL SYSTEM (JADA SYSTEM) DID NOT CONTROL BLEEDING (DEVICE INEFFECTIVE) FOR THE PATIENT. DUE TO UNSUCCESSFUL IN CONTROLLING BLEEDING, THE PATIENT ENDED UP WITH BAKRI BALLOON. ON AN UNKNOWN DATE, THERAPY WITH VACUUM-INDUCED HEMORRHAGE CONTROL SYSTEM (JADA SYSTEM) WAS DISCONTINUED. THE PATIENT SOUGHT MEDICAL ATTENTION. IT WAS REPORTED THAT VACUUM-INDUCED HEMORRHAGE CONTROL SYSTEM (JADA SYSTEM) CAME WITH BLUE SEAL VALVE. THE PHYSICIAN STATED THAT OF THE 20 VACUUM-INDUCED HEMORRHAGE CONTROL SYSTE

  Patient problems: Insufficient Information

  MAUDE report 15374302 ↗