SURGICEL FIBRILLAR 411963Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 10705031005211), received between May 31, 2023 and Dec 9, 2025 — classified as 4 injuries, 1 malfunction.

The most frequently reported specific device problem is “Device Contaminated During Manufacture or Shipping” (1 report).

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 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• InjuryDec 9, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT A HYSTERECTOMY PROCEDURE ON (B)(6) 2025 AND ABSORBABLE HEMOSTAT WAS USED. AFTER 15 DAYS OF THE PROCEDURE, ENDOMETRIOSIS AND HYSTERECTOMY, THE DOCTOR REPORTED THERE WAS A POSSIBLE REACTION TO THE ABSORBABLE HEMOSTAT. THE PATIENT PRESENTED PAIN AND SEROUS VAGINAL DISCHARGE ON THE THIRD POSTOPERATIVE DAY. VAGINAL IMAGING AND TOUCH TESTS WERE PERFORMED FOR ANALYSIS OF ENDOMETRIAL SUTURE. SEEN SEROUS DRAINAGE AND PERFORMED ANTIBIOTIC WASH AND STARTED FOR 7 DAYS (CIPROFLOXACIN AND METRONIDAZOLE). PATIENT IN FOLLOW-UP BY THE TEAM AND FINDS THEMSELF WELL. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: Abnormal Vaginal Discharge; Pain

  MAUDE report 23760438 ↗
• InjuryDec 2, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT A RECTUM PROCEDURE ON (B)(6) 2025 AND ABSORBABLE HEMOSTAT WAS USED. THE DOCTOR REPORTED THAT 3 PATIENTS DEVELOPED PELVIC FLUID COLLECTIONS DUE TO THE USE OF ABSORBABLE HEMOSTAT. ALL THREE HAD EARLY FEVER 48 TO 72 HOURS AFTER SURGERY. TESTS WERE PERFORMED, INCLUDING CT SCANS, AND THERE WAS NO INTESTINAL ANASTOMOSIS DEHISCENCE, BUT ALL SHOWED COLLECTIONS WITH GAS AND LIQUID COMPONENTS AT THE HEMOSTATIC SITES. RE-INTERVENTIONS REVEALED RESIDUAL HEMOSTATIC FLUID AND INFECTED COLLECTIONS. ALL WERE CONTAINED AT THE ONSET OF INFECTION. THE PATIENT DRAINED SPONTANEOUSLY; SHE HAD AN ASSOCIATED HYSTERECTOMY, AND THERE WAS SPONTANEOUS DRAINAGE, BUT OF PROLONGED DURATION, WHICH CAUSED DISTRESS FOR THE PATIENT. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: Fever; Hypervolemia; Unspecified Infection

  MAUDE report 23693429 ↗
• InjuryJul 30, 2025Adverse 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 DOCTOR REPORTED THAT TWO PATIENTS HAD PELVIC COLLECTIONS DUE TO THE USE OF ABSORBABLE HEMOSTAT. THE FIRST PATIENT DEVELOPED A FEVER ON THE THIRD DAY, AND THE SECOND DEVELOPED PAIN ON THE FOURTH DAY. THEY ATTEMPTED TO TREAT THE CONDITION CLINICALLY, BUT WITHOUT SUCCESS. BOTH WERE RE-TREATED ON THE SIXTH POSTOPERATIVE DAY. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: Fever; Pain; Unspecified Infection

  MAUDE report 22670584 ↗
• InjuryJul 30, 2025Adverse 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 DOCTOR REPORTED THAT TWO PATIENTS HAD PELVIC COLLECTIONS DUE TO THE USE OF ABSORBABLE HEMOSTAT. THE FIRST PATIENT DEVELOPED A FEVER ON THE THIRD DAY, AND THE SECOND DEVELOPED PAIN ON THE FOURTH DAY. THEY ATTEMPTED TO TREAT THE CONDITION CLINICALLY, BUT WITHOUT SUCCESS. BOTH WERE RE-TREATED ON THE SIXTH POSTOPERATIVE DAY. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: Fever; Hypervolemia; Unspecified Infection

  MAUDE report 22669796 ↗
• MalfunctionMay 31, 2023Device Contaminated During Manufacture or Shipping; Device Contaminated During Manufacture or Shipping

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE AND ABSORBABLE HEMOSTAT WAS USED. THE PRODUCT WAS OPENED IN THE THEATRE, UPON REMOVAL FROM THE PACK A CONTAMINATION WAS NOTED ON THE DEVICE. THE CONTAMINATE WAS SIMILAR IN SIZE, SHAPE AND COLOR TO HUMAN HAIR OR EYELASH. THE PRODUCT WAS REMOVED FROM THE STERILE FIELD. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17035035 ↗