SURGICEL 1952Recalls & reported problems

Summary

The FDA's MAUDE database contains 41 adverse event reports that list this exact device (DI 10705031003026), received between Sep 28, 2018 and Jul 3, 2025 — classified as 1 death, 20 injuries, 20 malfunctions.

The most frequently reported specific device problem is “Device Markings/Labelling Problem” (15 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. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.

Most reported problems

Recent adverse event reports

The 25 most recent of 41 reports, in the reporter's own words as published by the FDA.

• InjuryJul 3, 2025Material Integrity Problem; Material Integrity Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT A CERVICAL BIOPSY PROCEDURE ON AN UNKNOWN DATE AND ABSORBABLE HEMOSTAT WAS USED. DURING THE PROCEDURE THEY PLACED THE ABSORBABLE HEMOSTAT ON THE BIOPSY SITE. THE PATIENT CAME BACK WITH A CERVICAL FLUSH INFECTION. THEY ARE SAYING THAT THE ABSORBABLE HEMOSTAT IS NOT DISSOLVED LIKE TYPICALLY HAD IN THE PAST. THEY HAD TO TAKE BACK IN THE OFFICE AND PHYSICALLY REMOVED THE ABSORBABLE HEMOSTAT. BOTH OF THE PATIENT WERE HOSPITALIZED AFTER THE FACT DUE TO INFECTION. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: Unspecified Infection

  MAUDE report 22394861 ↗
• InjuryJul 3, 2025Material Integrity Problem; Material Integrity Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT A CERVICAL BIOPSY PROCEDURE ON AN UNKNOWN DATE AND ABSORBABLE HEMOSTAT WAS USED. DURING THE PROCEDURE THEY PLACED THE ABSORBABLE HEMOSTAT ON THE BIOPSY SITE. THE PATIENT CAME BACK WITH A CERVICAL FLUSH INFECTION. THEY ARE SAYING THAT THE ABSORBABLE HEMOSTAT IS NOT DISSOLVED LIKE TYPICALLY HAD IN THE PAST. THEY HAD TO TAKE BACK IN THE OFFICE AND PHYSICALLY REMOVED THE ABSORBABLE HEMOSTAT. BOTH OF THE PATIENT WERE HOSPITALIZED AFTER THE FACT DUE TO INFECTION. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: Unspecified Infection

  MAUDE report 22394682 ↗
• MalfunctionApr 30, 2025Device Markings/Labelling Problem; Device Markings/Labelling Problem

  IT WAS REPORTED THAT UNAUTHORIZED DISTRIBUTORS SELLING ABSORBABLE HEMOSTAT IN MINAS GERAIS. ONE BATCH WAS NOT DISTRIBUTED IN BRAZIL, IT HAS A LABEL THAT IS NOT FROM J&J ¿ DEVIATION CONFIRMED WITH THE POSSIBILITY OF BEING FAKE. TWO OTHER BATCHES WERE SOLD IN BRAZIL. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21938453 ↗
• MalfunctionApr 30, 2025Device Markings/Labelling Problem; Device Markings/Labelling Problem

  IT WAS REPORTED THAT UNAUTHORIZED DISTRIBUTORS SELLING ABSORBABLE HEMOSTAT IN MINAS GERAIS. ONE BATCH WAS NOT DISTRIBUTED IN BRAZIL, IT HAS A LABEL THAT IS NOT FROM J&J ¿ DEVIATION CONFIRMED WITH THE POSSIBILITY OF BEING FAKE. TWO OTHER BATCHES WERE SOLD IN BRAZIL. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21938430 ↗
• MalfunctionAug 14, 2024Delivered as Unsterile Product; Delivered as Unsterile Product

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE AND ABSORBABLE HEMOSTAT WAS USED. WHEN THEY OPENED THE BOX REMOVING THAT OUTER PLASTIC, THREE OF THE PACKETS WERE COMPLETELY SHREDDED WITHIN THE BOX. THEY WERE LIKE CHEWED UP. THE CUSTOMER RECEIVED THE PRODUCT BUT THE STERILE WRAP WAS OPEN AND THE THREE EACHES WERE OPEN. THERE WAS NO DAMAGE TO THE BROWN OUTER BOX. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19988249 ↗
• MalfunctionAug 14, 2024Delivered as Unsterile Product; Delivered as Unsterile Product

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE AND ABSORBABLE HEMOSTAT WAS USED. WHEN THEY OPENED THE BOX REMOVING THAT OUTER PLASTIC, THREE OF THE PACKETS WERE COMPLETELY SHREDDED WITHIN THE BOX. THEY WERE LIKE CHEWED UP. THE CUSTOMER RECEIVED THE PRODUCT BUT THE STERILE WRAP WAS OPEN AND THE THREE EACHES WERE OPEN. THERE WAS NO DAMAGE TO THE BROWN OUTER BOX. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19982620 ↗
• MalfunctionAug 14, 2024Delivered as Unsterile Product; Delivered as Unsterile Product

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE AND ABSORBABLE HEMOSTAT WAS USED. WHEN THEY OPENED THE BOX REMOVING THAT OUTER PLASTIC, THREE OF THE PACKETS WERE COMPLETELY SHREDDED WITHIN THE BOX. THEY WERE LIKE CHEWED UP. THE CUSTOMER RECEIVED THE PRODUCT BUT THE STERILE WRAP WAS OPEN AND THE THREE EACHES WERE OPEN. THERE WAS NO DAMAGE TO THE BROWN OUTER BOX. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19982160 ↗
• MalfunctionApr 18, 2024Device Markings/Labelling Problem; Device Markings/Labelling Problem

  IT WAS REPORTED THAT THE LOCAL TEAM RECEIVED EMPLOYEE FEEDBACK ABOUT SUSPECTED PRODUCTS FROM ON LINE SOURCES. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19130232 ↗
• MalfunctionMar 5, 2024Device Contaminated During Manufacture or Shipping; Device Contaminated During Manufacture or Shipping

  IT WAS REPORTED THAT A PATIENT UNDERWENT A CHOLECYSTECTOMY PROCEDURE ON AN UNKNOWN DATE AND SUTURE WAS USED. DURING THE SURGICAL PROCEDURE, THE SUTURE WAS REMOVED FROM ITS STERILE PACKAGING AND CIRCULATED TO AN INSTRUMENTATION TABLE WITH STERILE TECHNIQUE, THE SURGICAL SCRUB NURSE UNCOVERED THE SUTURE AND FINDS HAIR, THE GENERAL SURGEON WHO INDICATED TO REPORT AND DISCARD IT. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18839789 ↗
• InjuryFeb 22, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT A LIVER PROCEDURE (B)(6) 2024 AND ABSORBABLE HEMOSTAT WAS USED AS A PART OF A CLINICAL TRIAL. HEMOSTASIS WAS NOT ACHIEVED INTRA-OPERATIVELY AND A RESCUE THERAPY, ELECTROCAUTERY, WAS USED. THE RELATIONSHIP TO THE STUDY DEVICE IS UNKNOWN. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 18760336 ↗
• DeathFeb 6, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE AND ABSORBABLE HEMOSTAT WAS USED. THE 69 YEAR OLD, MALE PATIENT WAS DIAGNOSED WITH PLEUROPARENCHYMAL FIBROELASTOSIS (PPFE) AND WAS TREATED WITH HOME OXYGEN THERAPY. THE PATIENT DEVELOPED BILATERAL MILD PNEUMOTHORAX AND WAS FOLLOWED UP, BUT THE LEFT PNEUMOTHORAX PROGRESSED. AFTER THORACIC DRAINAGE, PLEURODESIS USING AUTOLOGOUS BLOOD WAS PERFORMED SIX TIMES, BUT WITHOUT SUCCESS. AFTER PLACING A DRAIN ON THE RIGHT SIDE, THORACOSCOPICALLY ASSISTED PULMONARY FISTULA CLOSURE WAS PERFORMED FOR THE LEFT PNEUMOTHORAX. A PULMONARY CYST WAS FOUND AT THE APEX OF THE LEFT UPPER LOBE OF THE LUNG, AND IT WAS JUDGED THAT IT WOULD BE DIFFICULT TO DISSECT IT WITH AN AUTOMATIC SUTURING DEVICE, SO THE BASE OF THE THICKENED PULMONARY CYST WAS LIGATED USING SILK THREAD. AFTER CLEANING THE THORACIC CAVITY, AN OXIDIZED CELLULOSE SHEET WAS PASTED AROUND THE LIGATED AREA, AND FIBRIN GLUE WAS APPLIED TO COMPLETE THE SURGERY. TO PREVENT ACUTE EXACERBATION OF INTERSTITIAL PNEUMONIA (IP), WE DEVISED A SURGICAL TECHNIQUE AND PERFORMED LUNG PROTECTIVE VENTILATION. THERE WERE NO POSTOPERATIVE COMPLICATIONS, AND THE PATIENT WAS DISCHAR

  Patient problems: Pneumonia; Pneumothorax

  MAUDE report 18653438 ↗
• InjuryFeb 6, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN ORTHO SPINE PROCEDURE ON AN UNKNOWN DATE AND ABSORBABLE HEMOSTAT WAS USED. THE ABSORBABLE HEMOSTAT WAS RETAINED PREVENT HEMATOMA, AND THE OPERATING SIDE SUCCESSFUL. UPON TWO WEEK FOLLOW UP THE PATIENT EXPERIENCED PAIN ON THE OPPOSITE SIDE AND REQUESTED THE SURGEON GO BACK IN TO REMOVE THE ABSORBABLE HEMOSTAT. THE SURGEON REMOVED THE EXCESS PRODUCT AND PATIENT RECOVERED WITH NO FURTHER CONCERNS. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: Pain

  MAUDE report 18653061 ↗
• MalfunctionAug 25, 2023Device Markings/Labelling Problem; Device Markings/Labelling Problem

  THE SUSPECTED ABSORBABLE HEMOSTAT PRODUCTS WERE FROM SIX DIFFERENT ONLINE SOURCES ON AN UNKNOWN DATE. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17623424 ↗
• InjuryAug 10, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT A TRACHEOTOMY PROCEDURE ON AN UNKNOWN DATE AND ABSORBABLE HEMOSTAT WAS USED. THE PATIENT WAS LEFT WITH A PART OF THE ABSORBABLE HEMOSTAT EXPOSED TO THE ENVIRONMENT AND APPARENTLY THIS GENERATED CONTAMINATION OF THE PRODUCT AND INFECTION. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: Bacterial Infection; Unspecified Infection

  MAUDE report 17497748 ↗
• MalfunctionApr 11, 2023Device Contaminated During Manufacture or Shipping; Device Contaminated During Manufacture or Shipping

  IT WAS REPORTED THAT ON AN UNKNOWN DATE THE SUTURE PRODUCT ARRIVED CONTAMINATED WITH BLOOD. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16714155 ↗
• MalfunctionFeb 7, 2023Device Markings/Labelling Problem; Device Markings/Labelling Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON (B)(6) 2023 AND ABSORBABLE HEMOSTAT WAS USED. BEFORE USE ON THE PATIENT, IT WAS REPORTED THAT THE IFU BOOKLET IS MISSING. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16313979 ↗
• MalfunctionDec 5, 2022Device Markings/Labelling Problem; Device Markings/Labelling Problem

  THE ABSORBABLE HEMOSTAT PRODUCT WAS RECEIVED WITHOUT THE INSTRUCTIONS FOR USE BOOKLET ON AN UNKNOWN DATE. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15916190 ↗
• InjuryJan 19, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT A PNEUMOTHORAX PROCEDURE ON (B)(6) 2019 AND ABSORBABLE HEMOSTAT WAS USED. THE PATIENT WAS A (B)(6) WOMAN, WHO COMPLAINED OF DYSPNEA. DUE TO LYMPHANGIOLEIOMYOMATOSIS AND REPEATED RIGHT PNEUMOTHORAX WHILE WAITING FOR A BRAIN-DEAD LUNG TRANSPLANT, THORACOSCOPIC TOTAL PLEUROCOVERAGE WAS PERFORMED. THE WHOLE PLEURA WAS COATED WITH 13 ABSORBABLE HEMOSTATS. THE OPERATION TIME WAS 2 HOURS AND 38 MINUTES. DYSPNEA AND DECREASED SPO2 DEVELOPED ON POSTOPERATIVE DAY 6. THERE WERE NO OBVIOUS ABNORMALITIES IN IMAGING TESTS, AND WHEEZE WAS HEARD, AND BRONCHIAL ASTHMA WAS DIAGNOSED. SYMPTOMS IMPROVED WITH DRIP INFUSION OF STEROID AND INHALATION OF PROCATEROL. ORAL ADMINISTRATION OF ANTIALLERGIC DRUGS WAS ALSO STARTED, BUT AN ASTHMATIC ATTACK RECURRED ON POSTOPERATIVE DAY 9, REQUIRING INHALATION OF PROCATEROL, AND NO FURTHER ATTACKS WERE OBSERVED. THE PATIENT HAD NO PAST HISTORY OF BRONCHIAL ASTHMA OR ALLERGY. SINCE AN INCREASE IN EOSINOPHILS WAS NOTED AFTER SURGERY, A DRUG INDUCED ALLERGY WAS SUSPECTED. NO NEW DRUG WAS STARTED IN THE PERIOPERATIVE PERIOD, AND ABSORBABLE HEMOSTAT AND PLASMA FRACTION PREPARATION USED DURING SURGERY WERE CONSIDERED AS SUSPECT.

  Patient problems: Asthma; Dyspnea; Hypersensitivity/Allergic reaction; Hypoxia

  MAUDE report 11194625 ↗
• InjuryJan 19, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT A PNEUMOTHORAX PROCEDURE ON (B)(6) 2019 AND ABSORBABLE HEMOSTAT WAS USED. THE PATIENT WAS A (B)(6) YEAR-OLD WOMAN, WHO COMPLAINED OF DYSPNEA. DUE TO LYMPHANGIOLEIOMYOMATOSIS AND REPEATED RIGHT PNEUMOTHORAX WHILE WAITING FOR A BRAIN-DEAD LUNG TRANSPLANT, THORACOSCOPIC TOTAL PLEUROCOVERAGE WAS PERFORMED. THE WHOLE PLEURA WAS COATED WITH 13 ABSORBABLE HEMOSTATS. THE OPERATION TIME WAS 2 HOURS AND 38 MINUTES. DYSPNEA AND DECREASED SPO2 DEVELOPED ON POSTOPERATIVE DAY 6. THERE WERE NO OBVIOUS ABNORMALITIES IN IMAGING TESTS, AND WHEEZE WAS HEARD, AND BRONCHIAL ASTHMA WAS DIAGNOSED. SYMPTOMS IMPROVED WITH DRIP INFUSION OF STEROID AND INHALATION OF PROCATEROL. ORAL ADMINISTRATION OF ANTIALLERGIC DRUGS WAS ALSO STARTED, BUT AN ASTHMATIC ATTACK RECURRED ON POSTOPERATIVE DAY 9, REQUIRING INHALATION OF PROCATEROL, AND NO FURTHER ATTACKS WERE OBSERVED. THE PATIENT HAD NO PAST HISTORY OF BRONCHIAL ASTHMA OR ALLERGY. SINCE AN INCREASE IN EOSINOPHILS WAS NOTED AFTER SURGERY, A DRUG INDUCED ALLERGY WAS SUSPECTED. NO NEW DRUG WAS STARTED IN THE PERIOPERATIVE PERIOD, AND ABSORBABLE HEMOSTAT AND PLASMA FRACTION PREPARATION USED DURING SURGERY WERE CONSIDERED AS

  Patient problems: Asthma; Dyspnea; Hypersensitivity/Allergic reaction; Hypoxia

  MAUDE report 11194562 ↗
• InjuryJan 19, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT A PNEUMOTHORAX PROCEDURE ON (B)(6) 2019 AND ABSORBABLE HEMOSTAT WAS USED. THE PATIENT WAS A (B)(6) WOMAN, WHO COMPLAINED OF DYSPNEA. DUE TO LYMPHANGIOLEIOMYOMATOSIS AND REPEATED RIGHT PNEUMOTHORAX WHILE WAITING FOR A BRAIN-DEAD LUNG TRANSPLANT, THORACOSCOPIC TOTAL PLEUROCOVERAGE WAS PERFORMED. THE WHOLE PLEURA WAS COATED WITH 13 ABSORBABLE HEMOSTATS. THE OPERATION TIME WAS 2 HOURS AND 38 MINUTES. DYSPNEA AND DECREASED SPO2 DEVELOPED ON POSTOPERATIVE DAY 6. THERE WERE NO OBVIOUS ABNORMALITIES IN IMAGING TESTS, AND WHEEZE WAS HEARD, AND BRONCHIAL ASTHMA WAS DIAGNOSED. SYMPTOMS IMPROVED WITH DRIP INFUSION OF STEROID AND INHALATION OF PROCATEROL. ORAL ADMINISTRATION OF ANTIALLERGIC DRUGS WAS ALSO STARTED, BUT AN ASTHMATIC ATTACK RECURRED ON POSTOPERATIVE DAY 9, REQUIRING INHALATION OF PROCATEROL, AND NO FURTHER ATTACKS WERE OBSERVED. THE PATIENT HAD NO PAST HISTORY OF BRONCHIAL ASTHMA OR ALLERGY. SINCE AN INCREASE IN EOSINOPHILS WAS NOTED AFTER SURGERY, A DRUG INDUCED ALLERGY WAS SUSPECTED. NO NEW DRUG WAS STARTED IN THE PERIOPERATIVE PERIOD, AND ABSORBABLE HEMOSTAT AND PLASMA FRACTION PREPARATION USED DURING SURGERY WERE CONSIDERED AS SUSPECT.

  Patient problems: Asthma; Dyspnea; Hypersensitivity/Allergic reaction; Hypoxia

  MAUDE report 11194546 ↗
• InjuryJan 15, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT A PNEUMOTHORAX SURGERY ON (B)(6) 2019 AND ABSORBABLE HEMOSTAT WAS USED. THE ABSORBABLE HEMOSTAT WAS LEFT IN THE PATIENT, THEN THE PATIENT HAD ASTHMA SYMPTOM AFTER THE SURGERY. THE SYMPTOM WAS NOT SERIOUS, BUT THE CAUSE IS UNKNOWN, SO A PATCH TEST IS PLANNED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: Asthma; Dyspnea; Hypersensitivity/Allergic reaction; Hypoxia

  MAUDE report 11182520 ↗
• InjuryJan 15, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT A PNEUMOTHORAX SURGERY ON (B)(6) 2019 AND ABSORBABLE HEMOSTAT WAS USED. THE ABSORBABLE HEMOSTAT WAS LEFT IN THE PATIENT, THEN THE PATIENT HAD ASTHMA SYMPTOM AFTER THE SURGERY. THE SYMPTOM WAS NOT SERIOUS, BUT THE CAUSE IS UNKNOWN, SO A PATCH TEST IS PLANNED. ADDITIONAL INFORMATION WAS REQUESTED

  Patient problems: Asthma; Dyspnea; Hypersensitivity/Allergic reaction; Hypoxia

  MAUDE report 11182517 ↗
• InjuryJan 15, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT A PNEUMOTHORAX SURGERY ON (B)(6) 2019 AND ABSORBABLE HEMOSTAT WAS USED. THE ABSORBABLE HEMOSTAT WAS LEFT IN THE PATIENT, THEN THE PATIENT HAD ASTHMA SYMPTOM AFTER THE SURGERY. THE SYMPTOM WAS NOT SERIOUS, BUT THE CAUSE IS UNKNOWN, SO A PATCH TEST IS PLANNED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: Asthma; Dyspnea; Hypersensitivity/Allergic reaction; Hypoxia

  MAUDE report 11182516 ↗
• InjuryJan 15, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT A PNEUMOTHORAX SURGERY ON (B)(6) 2019 AND ABSORBABLE HEMOSTAT WAS USED. THE ABSORBABLE HEMOSTAT WAS LEFT IN THE PATIENT, THEN THE PATIENT HAD ASTHMA SYMPTOM AFTER THE SURGERY. THE SYMPTOM WAS NOT SERIOUS, BUT THE CAUSE IS UNKNOWN, SO A PATCH TEST IS PLANNED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: Asthma; Dyspnea; Hypersensitivity/Allergic reaction; Hypoxia

  MAUDE report 11182513 ↗
• InjuryJan 15, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT A PNEUMOTHORAX SURGERY ON (B)(6) 2019 AND ABSORBABLE HEMOSTAT WAS USED. THE ABSORBABLE HEMOSTAT WAS LEFT IN THE PATIENT, THEN THE PATIENT HAD ASTHMA SYMPTOM AFTER THE SURGERY. THE SYMPTOM WAS NOT SERIOUS, BUT THE CAUSE IS UNKNOWN, SO A PATCH TEST IS PLANNED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: Asthma; Dyspnea; Hypersensitivity/Allergic reaction; Hypoxia

  MAUDE report 11182507 ↗