JADA System JADA-2002Recalls & reported problems

Summary

The FDA's MAUDE database contains 74 adverse event reports that list this exact device (DI 00840164521139), received between Feb 18, 2025 and Mar 24, 2026 — classified as 4 deaths, 66 injuries, 4 malfunctions.

The most frequently reported specific device problem is “Break” (3 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 74 reports, in the reporter's own words as published by the FDA.

• DeathMar 24, 2026Adverse Event Without Identified Device or Use Problem

  THIS IS AN AMENDMENT REPORT, F02 IMDRF CODE HAS BEEN ADDED.

  Patient problems: Disseminated Intravascular Coagulation (DIC); Hemorrhage/Blood Loss/Bleeding; Insufficient Information

  MAUDE report 24680972 ↗
• DeathFeb 3, 2026Component Incompatible; Component or Accessory Incompatibility; Compatibility Problem; Adverse Event Without Identified Device or Use Problem

  FOLLOW UP REPORT RECEIVED ON 12-FEB-2026. THIS IS AN INITIAL DEVICE RELATED REPORT. THE IMDRF CODES WERE ADDED.

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

  MAUDE report 24245400 ↗
• MalfunctionDec 3, 2025Fluid/Blood Leak; Fluid/Blood Leak

  THIS IS AN AMENDMENT REPORT: THE ADVERSE EVENT CHECKBOX WAS UNCHECKED IN MEDWATCH INFO SUB TAB. THIS CASE HAS BEEN DOWNGRADED AFTER FURTHER REVIEW AND NO LONGER MEETS CRITERIA FOR A DEVICE REPORTABLE EVENT. THE MALFUNCTION CHECKBOX WAS INCORRECTLY SELECTED EARLIER AND WOULD BE UPDATED CORRECTLY AFTER THIS ONE LAST SUBMISSION.

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

  MAUDE report 23706014 ↗
• InjuryOct 28, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THIS IS AN AMENDMENT REPORT. UPDATED DETERMINED CAUSALITY OF THE EVENT ABDOMINAL DISTENSION FROM UNKNOWN TO NOT ASSESSED AND TO CHECK PRODUCT PROBLEM CHECK BOX.

  Patient problems: Abdominal Distention; Hemorrhage/Blood Loss/Bleeding; Insufficient Information

  MAUDE report 23405908 ↗
• InjuryOct 2, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  FOLLOW UP REPORT RECEIVED ON 04-DEC-2025. THIS IS A FINAL REPORT. MANUFACTURING STATEMENT: NO COMPLAINT SAMPLE OR DEVICE LOT NUMBER ARE AVAILABLE FOR EVALUATION, THEREFORE AN UNKNOWN INVESTIGATION WAS PERFORMED. THE DEVICE IS ASSEMBLED PER SPECIFICATIONS WHERE IN-PROCESS AND FINAL INSPECTIONS ARE CONDUCTED BY TRAINED PERSONNEL. NO OUTCOME FROM THE INVESTIGATION COULD BE DETERMINED SINCE NO COMPLAINT SAMPLE OR LOT IDENTIFICATION HAS BEEN PROVIDED. IF THE COMPLAINT SAMPLE OR LOT NUMBER BECOME AVAILABLE, THIS COMPLAINT WILL BE RE-OPENED AND ADDITIONAL INVESTIGATION MAY BE PERFORMED. THIS IS ONE OF SEVERAL REPORTS RECEIVED FROM THE SAME REPORTER.

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

  MAUDE report 23199573 ↗
• InjuryOct 2, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT'S CERVIX WAS GETTING CLOGGED WITH CLOTS [DEVICE OCCLUSION]. DID THE JADA DEVICE STOP CONTROL THE BLEEDING? NO, IT WAS NEVER CONTROLLED [DEVICE INEFFECTIVE]. NO ADDITIONAL AES REPORTED [NO ADVERSE EVENT]. CASE NARRATIVE: THIS SPONTANEOUS REPORT ORIGINATING FROM UNITED STATES WAS RECEIVED FROM THE OFFICE MANAGER REFERRING TO A 35-YEAR-OLD FEMALE PATIENT. THE PATIENT'S HISTORICAL DRUGS INCLUDED METHYLERGOMETRINE MALEATE (METHERGINE), HEMOBATE AND MISOPROSTOL (RECTAL CYTOTEC). THE PATIENT'S OBSTETRIC HISTORY INCLUDED MULTIGRAVIDA (GRAVIDA 9) AND MULTIPAROUS (PARA 9). THE PATIENT'S CURRENT PREGNANCY WAS A SINGLETON, DELIVERED VIA CESAREAN SECTION DUE TO BREECH PRESENTATION. DELIVERY WAS NOT INDUCED. THE PATIENT HAD THE ESTIMATED BLOOD LOSS AROUND 1000 ML. THE BLOOD PRODUCTS REQUIRED DURING PERIPARTUM PERIOD AND 2 UNITS OF PRODUCTS AND VOLUME WAS TRANSFUSED. THE SUSPECTED CAUSE OF THE POSTPARTUM HEMORRHAGE WAS UTERINE ATONY. THE PATIENT'S ALLERGIES AND CONCOMITANT MEDICATIONS WERE NOT REPORTED. THIS REPORT CONCERNS 1 PATIENT(S) AND 1 DEVICE (S). ON (B)(6) 2025, THE PATIENT WAS PLACED WITH VACUUM-INDUCED HEMORRHAGE CONTROL SYSTEM (JADA SYSTEM) VIA TRANSVAGINAL ROUTE (LOT #, SERIAL

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

  MAUDE report 23199414 ↗
• DeathSep 19, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  FOLLOW UP INFORMATION RECEIVED FROM CLINICAL ACCOUNT SPECIALIST (CAS) ON (B)(6) 2025. ANOTHER HEATH CARE PROFESSIONAL (HCP) AT THE FACILITY NOT DIRECTLY INVOLVED IN THIS CASE STATED THAT THE PATIENT WAS SEPTIC AND HAD 20 VAGINAL EXAMS BY THE TIME HER WATER BAG HAD RUPTURED. THE PATIENT UNDERWENT "AN UNCOMPLICATED C-SECTION" WITH STABLE VITALS AND THEN AFTER THE DELIVERY SHE BEGAN TO HAVE A SHIFT IN VITALS. THE PATIENT RECEIVED 2 UNITS OF BLOOD PRODUCTS AT THAT TIME. HCP STATED THAT THE "PATIENT WAS DRY" AND CLOSED THE PATIENT UP. ONCE THE HCP CLOSED THE PATIENT UP, SHE STARTED TO DECOMPENSATE. THE DRAPE WAS PULLED BACK AND A "SIGNIFICANT AMOUNT" OF CLOTS AND BLOOD WAS NOTICED BETWEEN HER LEGS. THE HCP THEN INSERTED VACUUM-INDUCED HEMORRHAGE CONTROL SYSTEM (JADA SYSTEM) AND IT INITIALLY WORKED, AND EVERY 10-15 MINUTES THERE WAS 50 CC OF BLOOD AND CLOTS IN THE TUBE. THE ANESTHETIST BRIEFLY LEFT TO GET SUPPLIES TO CHECK HER HEMOGLOBIN AND WHILE SHE WAS GONE THE PATIENT CODED. THE PATIENT THEN RECEIVED 75 UNITS OF BLOOD PRODUCTS. THE HCP TRIED GETTING CONSENT FROM BOTH THE PATIENT'S HUSBAND AND SISTER TO LET HER PERFORM A HYSTERECTOMY FOR THE PATIENT BUT THEY BOTH REFUSED. THE HCP THEN

  Patient problems: Disseminated Intravascular Coagulation (DIC); Insufficient Information

  MAUDE report 23095789 ↗
• DeathSep 19, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  FOLLOW UP INFORMATION RECEIVED FROM CLINICAL ACCOUNT SPECIALIST (CAS) ON (B)(6) 2025. ANOTHER HEATH CARE PROFESSIONAL (HCP) AT THE FACILITY NOT DIRECTLY INVOLVED IN THIS CASE STATED THAT THE PATIENT WAS SEPTIC AND HAD 20 VAGINAL EXAMS BY THE TIME HER WATER BAG HAD RUPTURED. THE PATIENT UNDERWENT "AN UNCOMPLICATED C-SECTION" WITH STABLE VITALS AND THEN AFTER THE DELIVERY SHE BEGAN TO HAVE A SHIFT IN VITALS. THE PATIENT RECEIVED 2 UNITS OF BLOOD PRODUCTS AT THAT TIME. HCP STATED THAT THE "PATIENT WAS DRY" AND CLOSED THE PATIENT UP. ONCE THE HCP CLOSED THE PATIENT UP, SHE STARTED TO DECOMPENSATE. THE DRAPE WAS PULLED BACK AND A "SIGNIFICANT AMOUNT" OF CLOTS AND BLOOD WAS NOTICED BETWEEN HER LEGS. THE HCP THEN INSERTED VACUUM-INDUCED HEMORRHAGE CONTROL SYSTEM (JADA SYSTEM) AND IT INITIALLY WORKED, AND EVERY 10-15 MINUTES THERE WAS 50 CC OF BLOOD AND CLOTS IN THE TUBE. THE ANESTHETIST BRIEFLY LEFT TO GET SUPPLIES TO CHECK HER HEMOGLOBIN AND WHILE SHE WAS GONE THE PATIENT CODED. THE PATIENT THEN RECEIVED 75 UNITS OF BLOOD PRODUCTS. THE HCP TRIED GETTING CONSENT FROM BOTH THE PATIENT'S HUSBAND AND SISTER TO LET HER PERFORM A HYSTERECTOMY FOR THE PATIENT BUT THEY BOTH REFUSED. THE HCP THEN

  Patient problems: Disseminated Intravascular Coagulation (DIC); Insufficient Information

  MAUDE report 23095570 ↗
• InjurySep 12, 2025Adverse Event Without Identified Device or Use Problem; Lack of Effect; Adverse Event Without Identified Device or Use Problem; Lack of Effect

  FOLLOW UP INFORMATION WAS RECEIVED FROM QUALITY INVESTIGATION TEAM ON 12-JAN-2026. MANUFACTURING STATEMENT: NO COMPLAINT SAMPLE OR DEVICE LOT NUMBER ARE AVAILABLE FOR EVALUATION; THEREFORE AN UNKNOWN INVESTIGATION WAS PERFORMED. THE DEVICE IS ASSEMBLED PER SPECIFICATIONS WHERE IN-PROCESS AND FINAL INSPECTIONS ARE CONDUCTED BY TRAINED PERSONNEL. NO OUTCOME FROM THE INVESTIGATION COULD BE DETERMINED SINCE NO COMPLAINT SAMPLE OR LOT IDENTIFICATION HAS BEEN PROVIDED. IF THE COMPLAINT SAMPLE OR LOT NUMBER BECOME AVAILABLE, THIS COMPLAINT WILL BE RE-OPENED AND ADDITIONAL INVESTIGATION MAY BE PERFORMED.

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

  MAUDE report 23038449 ↗
• InjurySep 10, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  FOLLOW UP RECEIVED ON 25-NOV-2025. THIS IS FINAL DEVICE RELATED REPORT. NO COMPLAINT SAMPLE OR DEVICE LOT NUMBER WERE AVAILABLE FOR EVALUATION; THEREFORE, AN UNKNOWN INVESTIGATION WAS PERFORMED. THE DEVICE WAS ASSEMBLED PER SPECIFICATIONS WHERE IN-PROCESS AND FINAL INSPECTIONS WERE CONDUCTED BY TRAINED PERSONNEL. NO OUTCOME FROM THE INVESTIGATION COULD BE DETERMINED SINCE NO COMPLAINT SAMPLE OR LOT IDENTIFICATION HAD BEEN PROVIDED. IF THE COMPLAINT SAMPLE OR LOT NUMBER BECOME AVAILABLE, THIS COMPLAINT WILL BE RE-OPENED, AND ADDITIONAL INVESTIGATION MAY BE PERFORMED.

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

  MAUDE report 23015040 ↗
• MalfunctionSep 9, 2025Break; Fracture; Material Integrity Problem; Break; Fracture; Material Integrity Problem

  CORRECTION MADE ON 20-APR-2026 TO THE CASE COMMENTS.

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

  MAUDE report 23004443 ↗
• InjuryAug 26, 2025Break; Fracture; Inflation Problem; Leak/Splash; Mechanical Problem; Infusion or Flow Problem; Material Integrity Problem; Adverse Event Without Identified Device or Use Problem; Break; Fracture; Inflation Problem; Leak/Splash; Mechanical Problem; Infusion or Flow Problem; Material Integrity Problem; Adverse Event Without Identified Device or Use Problem

  FOLLOW UP INFORMATION WAS RECEIVED FROM QUALITY INVESTIGATION TEAM ON 05-DEC-2025. THIS IS A FINAL REPORT. MANUFACTURING STATEMENT: NO COMPLAINT SAMPLE OR DEVICE LOT NUMBER ARE AVAILABLE FOR EVALUATION; THEREFORE, AN UNKNOWN INVESTIGATION WAS PERFORMED. THE DEVICE IS ASSEMBLED PER SPECIFICATIONS WHERE IN-PROCESS AND FINAL INSPECTIONS ARE CONDUCTED BY TRAINED PERSONNEL. NO OUTCOME FROM THE INVESTIGATION COULD BE DETERMINED SINCE NO COMPLAINT SAMPLE OR LOT IDENTIFICATION HAS BEEN PROVIDED. IF THE COMPLAINT SAMPLE OR LOT NUMBER BECOME AVAILABLE, THIS COMPLAINT WILL BE RE-OPENED AND ADDITIONAL INVESTIGATION MAY BE PERFORMED.

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

  MAUDE report 22894712 ↗
• InjuryAug 20, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THIS IS AN AMENDED REPORT: ADDED SERIOUSNESS CRITERIA FOR EVENT UTERINE ARTERY EMBOLIZATION AS 'MEDICALLY SIGNIFICANT'. ADDED 'THE UTERINE ATONY WAS THE SUSPECTED CAUSE OF POSTPARTUM HEMORRHAGE' IN THE NARRATIVE. UPDATED NARRATIVE FROM ¿THE BLOOD WAS STAYED IN THE TUBING¿ TO ¿THE BLOOD STAYED IN THE TUBING¿. REMOVED RECEIVED FROM DPOC FROM REFERENCES.

  Patient problems: Insufficient Information

  MAUDE report 22847834 ↗
• InjuryJul 7, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT THEN STARTED BLEEDING AROUND THE SEAL, SO PHYSICIAN REMOVED THE JADA [DEVICE INEFFECTIVE]. PHYSICIAN THEN PUT ADDITIONAL FLUID IN THE JADA SEAL FOR A TOTAL OF 300 MLS IN THE SEAL/ PUT THE JADA BACK IN [WRONG TECHNIQUE IN DEVICE USAGE PROCESS]. CASE NARRATIVE: THIS SPONTANEOUS REPORT ORIGINATING FROM UNITED STATES WAS RECEIVED FROM A PHYSICIAN, REFERRING TO A FEMALE PATIENT OF UNKNOWN AGE, VIA MEDICAL SCIENCE LIAISON (MSL), VIA CLINICAL SALES TERRITORY MANAGER. THE PATIENT HAD PRE-ECLAMPSIA, PLACENTA ACCRETA AND OTHER UNKNOWN COMORBIDITIES. THE PATIENT HAD GIVEN BIRTH IN THE PAST. THIS WAS PATIENT'S SINGLETON PREGNANCY AND HAD VAGINAL DELIVERY AT THE TERM. THIS WAS PATIENT'S SECOND OR THIRD BABY. THE PATIENT WAS GIVEN SOME MEDICATIONS PRIOR TO PLACEMENT OF THE VACUUM-INDUCED HEMORRHAGE CONTROL SYSTEM (JADA SYSTEM). THE TOTAL ESTIMATED LOSS OF BLOOD WAS 4250 ML. THE PATIENT'S DRUG REACTIONS OR ALLERGIES AND CONCOMITANT MEDICATIONS WERE NOT REPORTED. THIS REPORT CONCERNS 1 PATIENT(S) AND 1 DEVICE(S). ON (B)(6) 2025, THE VACUUM-INDUCED HEMORRHAGE CONTROL SYSTEM (JADA SYSTEM) 2.0 (LOT NUMBER# AND EXPIRATION DATE WAS NOT REPORTED) VIA INTRAUTERINE ROUTE INSERTED, BY THE TRAINED P

  Patient problems: Hemorrhage/Blood Loss/Bleeding; Insufficient Information

  MAUDE report 22410043 ↗
• InjuryJul 4, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  HCP ATTEMPTED JADA SYSTEM USE, BUT IT DID NOT SUCCESSFULLY TREAT THE PATIENT'S POST-PARTUM HEMORRHAGING. CLOTS WERE CLOGGING THE TUBING [DEVICE INEFFECTIVE], CLOTS WERE CLOGGING THE TUBING [DEVICE OCCLUSION] , NO ADDITIONAL AE REPORTED [NO ADVERSE EVENT] . CASE NARRATIVE: THIS SPONTANEOUS REPORT ORIGINATING FROM UNITED STATES WAS RECEIVED FROM A NURSE MANAGER, ON BEHALF OF PHYSICIAN, REFERRING TO A FEMALE PATIENT OF UNKNOWN AGE, VIA FIELD EMPLOYEE. 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 (B)(6) 2025, THE PATIENT WAS PLACED WITH VACUUM-INDUCED HEMORRHAGE CONTROL SYSTEM (JADA SYSTEM) 2.0 VAGINALLY (LOT #, SERIAL # AND EXPIRATION DATE WERE NOT REPORTED) FOR POSTPARTUM HEMORRHAGE. ON (B)(6) 2025, THE HEALTHCARE PROFESSIONAL (HCP) ATTEMPTED THE VACUUM-INDUCED HEMORRHAGE CONTROL SYSTEM (JADA SYSTEM) USE, BUT IT DID NOT SUCCESSFULLY TREAT THE PATIENT'S POST-PARTUM HEMORRHAGING (DEVICE INEFFECTIVE), CLOTS WERE CLOGGING THE TUBING (DEVICE OCCLUSION), SO THE VACUUM-INDUCED HEMORRHAGE CONTROL SYSTEM (JADA S

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

  MAUDE report 22404860 ↗
• InjuryJul 3, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT TREATED WITH JADA BUT FAILED AND PATIENT HAVE TO GO FOR HYSTERECTOMY "[DEVICE INEFFECTIVE]" , DR THINK IT FAILED POSSIBLY DUE TO HER PREVIOUS SCAR WAS VERY THIN AND MAYBE BECAUSE OF SUCTION OF JADA CAUSING IT TO DEHISCE "[UTERINE DEHISCENCE]" , DR THINK IT FAILED POSSIBLY DUE TO HER PREVIOUS SCAR WAS VERY THIN AND MAYBE BECAUSE OF SUCTION OF JADA CAUSING IT TO DEHISCE "[INJURY ASSOCIATED WITH DEVICE]" . CASE NARRATIVE: THIS SPONTANEOUS REPORT ORIGINATING FROM MALAYSIA WAS RECEIVED FROM PHYSICIAN REFERRING TO A FEMALE PATIENT OF UNKNOWN AGE VIA DESIGNATED POINT OF CONTACT AND COMPANY REPRESENTATIVE. THE PATIENT HAD HISTORY OF SCAR WHICH WAS VERY THIN. THE PATIENT'S CURRENT CONDITION, 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 THE VACUUM-INDUCED HEMORRHAGE CONTROL SYSTEM (JADA SYSTEM) 2002 VIA VAGINAL ROUTE (DEFAULTED), (LOT/BATCH# NUMBER AND EXPIRATION DATE WERE NOT REPORTED) FOR AN UNKNOWN INDICATION. ON AN UNKNOWN DATE, THE PATIENT TREATED WITH VACUUM-INDUCED HEMORRHAGE CONTROL SYSTEM (JADA SYSTEM) BUT FAILED AND PATIENT HAVE TO GO FOR HYSTER

  Patient problems: Hemorrhage/Blood Loss/Bleeding; Insufficient Information; Organ Dehiscence

  MAUDE report 22393016 ↗
• InjuryJul 1, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE JADA AND IT WASN'T WORKING TO CONTROL THE PATIENT'S BLEEDING [DEVICE INEFFECTIVE] THERE WAS A DEHISCENCE OF THE PATIENT'S INCISION, WHICH THEY BELIEVED COULD HAVE BEEN CAUSED FROM EITHER THE JADA DEVICE OR VIGOROUS FUNDAL RUBBING. [UTERINE DEHISCENCE] THEY BELIEVED COULD HAVE BEEN CAUSED FROM EITHER THE JADA DEVICE OR VIGOROUS FUNDAL RUBBING. [INJURY ASSOCIATED WITH DEVICE] CASE NARRATIVE: THIS SPONTANEOUS REPORT ORIGINATING FROM UNITED STATES WAS RECEIVED FROM A PHYSICIAN REFERRING TO A FEMALE PATIENT OF UNKNOWN AGE VIA CLINICAL ACCOUNT SPECIALIST (CAS). APPROXIMATELY ON AN UNKNOWN DATE IN 2025 (ALSO REPORTED AS SOMETIME A COUPLE WEEKS), THE PATIENT HAD C-SECTION. SHE STARTED BLEEDING IN THE RECOVERY ROOM. THE PATIENT RECEIVED OXYTOCIN (PITOCIN) AND METHYLERGOMETRINE MALEATE (METHERGINE) (AT AN UNKNOWN TIME DURING THIS EVENT). 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). APPROXIMATELY ON AN UNKNOWN DATE IN 2025 (ALSO REPORTED AS SOMETIME A COUPLE WEEKS AGO) (DISCREPANT INFORMATION, AS ALSO REPORTED AS SOMETIME TWO WEEKS AGO), THE PATIENT WAS PLACED WITH VACUUM-

  Patient problems: Hemorrhage/Blood Loss/Bleeding; Insufficient Information; Wound Dehiscence

  MAUDE report 22372952 ↗
• InjuryJun 30, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  CALLER REPORTS "THEY DO NOT BELIEVE IT WAS A DEVICE FAILURE, BUT THE JADA SYSTEM DID NOT WORK EITHER, AND LEAD TO A HYSTERECTOMY [DEVICE INEFFECTIVE] NO OTHER AE REPORTED, NO PQC REPORTED. [NO ADVERSE EVENT]. CASE NARRATIVE: THIS SPONTANEOUS REPORT ORIGINATING FROM UNITED STATES WAS RECEIVED FROM A CLINICAL NURSE LEADER REFERRING TO A FEMALE PATIENT OF UNKNOWN AGE VIA CLINICAL ACCOUNT SPECIALIST (CAS). THE PATIENT HAD SINGLETON PREGNANCY AND UNDERWENT A CESAREAN SECTION FOR DELIVERY. THE PATIENT'S CURRENT CONDITIONS, PAST DRUG REACTIONS/ALLERGIES AND CONCOMITANT MEDICATIONS WERE NOT REPORTED. THIS REPORT CONCERNS 1 PATIENT(S) AND 1 DEVICE(S). APPROXIMATELY IN (B)(6) 2025 (ALSO REPORTED AS ABOUT A WEEK AGO), THE HEALTHCARE PROFESSIONAL (HCP) USED A VACUUM-INDUCED HEMORRHAGE CONTROL SYSTEM (JADA SYSTEM) 2.0 VIA VAGINAL ROUTE (LOT #, SERIAL # AND EXPIRATION DATE WERE NOT REPORTED) IN THE LATE STAGES OF POST-PARTUM HEMORRHAGE FOR A PATIENT AFTER A FAILED BALLOON TAMPONADE (HISTORICAL DEVICE). THE HCP DID NOT BELIEVE IT WAS A DEVICE FAILURE, BUT THE VACUUM-INDUCED HEMORRHAGE CONTROL SYSTEM (JADA SYSTEM) DID NOT WORK EITHER/ THE VACUUM-INDUCED HEMORRHAGE CONTROL SYSTEM (JADA SYSTEM) WORK

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

  MAUDE report 22355990 ↗
• InjuryJun 27, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A 2ND SYSTEM WAS INSERTED. HCP WAS UNABLE TO SUCCESSFULLY TREAT THE PATIENT WITH THE 2ND SYSTEM AND HAD TO PERFORM ADDITIONAL INTERVENTIONS [DEVICE INEFFECTIVE]. NO ADDITIONAL AE REPORTED [NO ADVERSE EVENT]. CASE NARRATIVE: THIS SPONTANEOUS REPORT ORIGINATING FROM UNITED STATES WAS RECEIVED FROM A NURSE MANAGER, ON BEHALF OF PHYSICIAN, REFERRING TO A FEMALE PATIENT OF UNKNOWN AGE, VIA FIELD EMPLOYEE. 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 (B)(6) 2025, THE PATIENT WAS PLACED WITH VACUUM-INDUCED HEMORRHAGE CONTROL SYSTEM (JADA SYSTEM) 2.0 VIA VAGINAL ROUTE (LOT #, SERIAL # AND EXPIRATION DATE WERE NOT REPORTED) FOR POSTPARTUM HEMORRHAGE. THIS CASE WAS LINKED TO SAME PATIENT LINKED CASE INCLUDED, ON (B)(6) 2025, THE HEALTHCARE PROFESSIONAL (HCP) ATTEMPTED THE VACUUM-INDUCED HEMORRHAGE CONTROL SYSTEM (JADA SYSTEM) USE, BUT IT DID NOT SUCCESSFULLY TREAT THE PATIENT'S POST-PARTUM HEMORRHAGING, CLOTS WERE CLOGGING THE TUBING, SO THE VACUUM-INDUCED HEMORRHAGE CONTROL SYSTEM (JADA SYSTEM) WAS REMOVED ON

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

  MAUDE report 22347730 ↗
• InjuryMay 19, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  JADA FAILED AND HAD TO ESCALATE TO UAE [DEVICE INEFFECTIVE] IT WAS REPORTED THAT THE PROVIDER DID NOT THINK IT WAS A JADA ERROR BUT SHE THINKS IT WAS A USER ERROR AND THINKS SHE SHOULD HAVE PUMPED UP THE SUCTION TO 90 MM HG INSTEAD OF 80MM HG. [DEVICE USE ISSUE], NO ADDITIONAL AE REPORTED, NO PQC REPORTED [NO ADVERSE EVENT] . CASE NARRATIVE: THIS INITIAL SPONTANEOUS REPORT ORIGINATING FROM THE UNITED STATES, WAS RECEIVED FROM CLINICAL EDUCATOR (CE) ON BEHALF OF PHYSICIAN REFERRING TO FEMALE PATIENT OF UNKNOWN AGE. THE PATIENT'S MEDICAL HISTORY, DRUG REACTIONS OR ALLERGIES, CURRENT CONDITIONS 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) 2.0 VIA VAGINAL ROUTE (DEFAULTED) (LOT #, SERIAL # AND EXPIRATION DATE WERE NOT REPORTED) FOR AN UNKNOWN INDICATION. CE STATED THAT PROVIDER SENT HER A CASE STUDY DOCUMENT IN WHICH VACUUM-INDUCED HEMORRHAGE CONTROL SYSTEM (JADA SYSTEM) FAILED (DEVICE INEFFECTIVE) AND HAD TO ESCALATE TO UTERINE ARTERY EMBOLIZATION (UAE). THE PHYSICIAN DID NOT THINK IT WAS A VACUUM-INDUCED HEMORRHAGE CONTROL SYSTEM

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

  MAUDE report 22044072 ↗
• InjuryMay 8, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A 2ND JADA WAS PLACED BY HCP. PATIENT WAS MOVED TO THE ICU. JADA SYSTEM DID NOT WORK [DEVICE INEFFECTIVE]. THE DEVICE WAS NOT INSERTED CORRECTLY [DEVICE USE ERROR]. CASE NARRATIVE: THIS SPONTANEOUS REPORT ORIGINATING FROM UNITED STATES WAS RECEIVED FROM A PHYSICIAN, REFERRING TO A FEMALE PATIENT OF UNKNOWN AGE, VIA TERRITORY MANAGER (TM). THE PATIENT'S CONCOMITANT MEDICATIONS AND PAST DRUG REACTIONS/ALLERGIES WERE NOT REPORTED. THE PATIENT'S CURRENT CONDITION WAS GRAVIDA 3. ON (B)(6) 2025, THE PATIENT PRESENTED TO THE HOSPITAL (HOSPITALIZED) IN ACTIVE LABOR AND DELIVERED QUICKLY. 20 MINUTES LATER DELIVERY, THE PATIENT EXPERIENCED POSTPARTUM HEMORRHAGE (PPH) AND WAS MOVED TO THE OBSTETRICIAN (OB) FLOOR. THE TM STATED THE NURSE TOLD HER THAT ALL OF THE MEDICATIONS TO STOP THE PPH WERE ADMINISTERED UNSUCCESSFULLY. IT WAS BELIEVED THE PATIENT HAD AN ESTIMATED BLOOD LOSS (EBL) OF 2000. THEN THE VACUUM-INDUCED HEMORRHAGE CONTROL SYSTEM (JADA SYSTEM) WAS INSERTED BY PHYSICIAN, AND IT WORKED FOR 1 TO 2 HOURS BEFORE THE PATIENT STARTED BLEEDING AGAIN. PATIENT WAS TAKEN TO THE OPERATING ROOM (OR) WHERE JADA SYSTEM WAS REMOVED AND A DILATATION AND CURETTAGE (D&C) PERFORMED. THIS REPORT CONCER

  Patient problems: Hemorrhage/Blood Loss/Bleeding; Insufficient Information

  MAUDE report 21983736 ↗
• InjuryMay 7, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  JADA SYSTEM WAS INSERTED BY HCP AND IT WORKED FOR 1 TO 2 HOURS BEFORE THE PATIENT STARTED BLEEDING AGAIN. [DEVICE INEFFECTIVE], THE DEVICES WERE NOT INSERTED CORRECTLY THAT WAS USER ERROR ON HEALTHCARE PROFESSIONAL [DEVICE USE ERROR] . CASE NARRATIVE: THIS SPONTANEOUS REPORT ORIGINATING FROM UNITED STATES WAS RECEIVED FROM A PHYSICIAN, REFERRING TO A FEMALE PATIENT OF UNKNOWN AGE, VIA TERRITORY MANAGER (TM). THE PATIENT PRESENTED TO THE HOSPITAL IN ACTIVE LABOR AND DELIVERED QUICKLY, 20 MINUTES LATER, THE PATIENT EXPERIENCED POSTPARTUM HEMORRHAGE (PPH). TM STATED THAT THE NURSE TOLD HER THAT ALL OF THE MEDICATIONS TO STOP THE PPH WERE ADMINISTERED UNSUCCESSFULLY, AND IT WAS BELIEVED THE PATIENT HAD AN ESTIMATED BLOOD LOSS (EBL) OF 2000. THE PATIENT'S CURRENT CONDITION WAS GRAVIDA 3. 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) 2025, THE PATIENT WAS PLACED WITH VACUUM-INDUCED HEMORRHAGE CONTROL SYSTEM (JADA SYSTEM) 2.0 VIA INTRAVAGINAL ROUTE (LOT #, SERIAL # AND EXPIRATION DATE WAS NOT REPORTED) FOR POSTPARTUM HEMORRHAGE. THE VACUUM-INDUCED HEMORRHAGE CONTROL SYSTEM (JADA SYSTE

  Patient problems: Hemorrhage/Blood Loss/Bleeding; Insufficient Information

  MAUDE report 21976390 ↗
• InjuryApr 29, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  SAYS HER UTERINE ARTERY WAS SEVERED [ARTERIAL INJURY] VAGINA, UTERUS AND CERVIX WERE LACERATED [UTERINE CERVICAL LACERATION] VAGINA, UTERUS AND CERVIX WERE LACERATED [VULVOVAGINAL INJURY] NOW SHE COULD NO LONGER HAVE CHILDREN [INFERTILITY FEMALE] SAME JADA SYSTEM WAS USED TWICE WITHOUT SUCCESSFULLY STOPPING THE BLEEDING [DEVICE INEFFECTIVE] JAGGED CUT FROM USING THE JADA SYSTEM [INJURY ASSOCIATED WITH DEVICE] I DON'T THINK THEY KNEW HOW TO USE IT CORRECTLY/SAME JADA SYSTEM WAS USED TWICE [WRONG TECHNIQUE IN DEVICE USAGE PROCESS]. CASE NARRATIVE: THIS SPONTANEOUS REPORT ORIGINATING FROM UNITED STATES WAS RECEIVED FROM A FEMALE PATIENT OF UNKNOWN AGE REFERRING TO HERSELF. THE PATIENT HAD A CESARIAN SECTION ON (B)(6) 2024. THE PATIENT'S DRUG REACTIONS OR ALLERGIES AND CONCOMITANT MEDICATIONS WERE NOT REPORTED. THIS REPORT CONCERNS 1 PATIENT(S) AND 1 DEVICE(S). ON (B)(6) 2024, THE PATIENT WAS PLACED WITH THE VACUUM-INDUCED HEMORRHAGE CONTROL SYSTEM (JADA SYSTEM) 2002, VIA INTRAVAGINALLY (STRENGTH, DOSE, FREQUENCY, LOT/BATCH# NUMBER AND EXPIRATION DATE WERE NOT REPORTED) FOR POST-PARTUM HEMORRHAGE. ON (B)(6) 2024, THE PATIENT'S VAGINA, UTERUS AND CERVIX WERE LACERATED (VULVOVAGINAL INJU

  Patient problems: Hemorrhage/Blood Loss/Bleeding; Insufficient Information; Laceration(s); Perforation of Vessels

  MAUDE report 21924667 ↗
• InjuryApr 28, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THEY SHOULD KNOW ABOUT ANOTHER JADA HAS PERFORATED A UTERUS [UTERINE PERFORATION]. CASE NARRATIVE: THIS SPONTANEOUS REPORT ORIGINATING FROM UNITED STATES WAS RECEIVED FROM A CONSUMER REFERRING TO A FEMALE PATIENT OF UNKNOWN AGE. THE PATIENT'S MEDICAL HISTORY, DRUG REACTIONS OR ALLERGIES, CONCURRENT CONDITIONS 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 THE VACUUM-INDUCED HEMORRHAGE CONTROL SYSTEM (JADA SYSTEM) 2002 VIA VAGINAL ROUTE (DEFAULTED) (STRENGTH, DOSE, FREQUENCY, LOT/BATCH# NUMBER AND EXPIRATION DATE WERE NOT REPORTED) FOR AN UNKNOWN INDICATION. IT WAS REPORTED THAT, THEY SHOULD KNOW ABOUT ANOTHER VACUUM-INDUCED HEMORRHAGE CONTROL SYSTEM (JADA SYSTEM) HAS PERFORATED A UTERUS (UTERINE PERFORATION). SHE HEARD THIS BEFORE THAT A VACUUM-INDUCED HEMORRHAGE CONTROL SYSTEM (JADA SYSTEM) CAUSED A PERFORATED UTERUS. THE OUTCOME OF UTERINE PERFORATION WAS UNKNOWN. THE REPORTER CONSIDERED UTERINE PERFORATION TO BE RELATED TO VACUUM-INDUCED HEMORRHAGE CONTROL SYSTEM (JADA SYSTEM). UPON INTERNAL REVIEW, THE EVENT UTERINE PERFORATION WAS DETERMINED TO BE MEDICALLY SIGNIFICANT. THIS IS O

  Patient problems: Uterine Perforation

  MAUDE report 21917252 ↗
• InjuryApr 22, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  2ND JADA SYSTEM WAS PLACED AND WORKED AS IT SHOULD. PATIENT WAS TAKEN TO INTERVENTIONAL RADIOLOGY FOR UNKNOWN PROCEDURE WHERE BLEEDING WAS STOPPED AND JADA WAS REMOVED. [DEVICE INEFFECTIVE]. CASE NARRATIVE: THIS SPONTANEOUS REPORT ORIGINATING FROM UNITED STATES WAS RECEIVED FROM A NURSE REFERRING TO A FEMALE PATIENT OF AN UNKNOWN AGE VIA CLINICAL ACCOUNT SPECIALIST (CAS). THE PATIENT CAME INTO THE HOSPITAL IN ACTIVE LABOR, GESTATION UNKNOWN, GRAVIDA (G5), PARITY 4 (P4), WITH A HISTORY OF 4 PREVIOUS POSTPARTUM HEMORRHAGES. THE PATIENT GIVEN A LIVE BIRTH IN THE PAST WITH HISTORY OF ABNORMAL POSTPARTUM UTERINE BLEEDING OR HEMORRHAGE. THE PATIENT DELIVERED VAGINALLY BY MIDWIFE AND AFTER DELIVERY PATIENT EXPERIENCE UTERINE ATONY. THE PATIENT'S CURRENT PREGNANCY TYPE WAS SINGLETON. THE PATIENT PAST DRUGS/ALLERGIES, CONCOMITANT MEDICATIONS WERE NOT REPORTED. THIS REPORT CONCERNS 1 PATIENT(S) AND 1 DEVICE(S). ON AN UNKNOWN DATE, THE VACUUM-INDUCED HEMORRHAGE CONTROL SYSTEM (JADA SYSTEM) WAS PLACED, LEFT IN PLACE FOR 90 MINUTES CONNECTED TO SUCTION. THE SUCTION WAS TURNED OFF AND DEVICE WAS LEFT IN PLACE FOR 30 MINUTES WITH NO FURTHER BLEEDING, DEVICE WAS REMOVED. THE BLEEDING WAS CONTINUED

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 21880430 ↗