SURGICEL FIBRILLAR 411961Recalls & reported problems

Summary

The FDA's MAUDE database contains 9 adverse event reports that list this exact device (DI 10705031005198), received between Dec 9, 2020 and Aug 29, 2024 — classified as 9 malfunctions.

The most frequently reported specific device problem is “Component Missing” (6 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 9 most recent of 9 reports, in the reporter's own words as published by the FDA.

• MalfunctionAug 29, 2024Delivered as Unsterile Product; Component Missing; Delivered as Unsterile Product; Component Missing

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE AND AN ABSORBABLE HEMOSTAT WAS USED. WHEN PREPARING FOR OR AND PICKING PRODUCT THE NURSE FOUND THE SURGICEL FOIL NOT SEALED AND EMPTY. NO PRODUCT ENVELOPE OCH SURGICEL FIBRILLAR. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20096699 ↗
• MalfunctionAug 29, 2024Delivered as Unsterile Product; Component Missing; Delivered as Unsterile Product; Component Missing

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE AND AN ABSORBABLE HEMOSTAT WAS USED. WHEN PREPARING FOR OPERATING ROOM AND PICKING PRODUCT THE NURSE FOUND THE SURGICEL FOIL NOT SEALED AND EMPTY. NO PRODUCT ENVELOPE OCH SURGICEL FIBRILLAR. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20096695 ↗
• MalfunctionAug 29, 2024Delivered as Unsterile Product; Component Missing; Delivered as Unsterile Product; Component Missing

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE AND AN ABSORBABLE HEMOSTAT WAS USED. WHEN PREPARING FOR OR AND PICKING PRODUCT THE NURSE FOUND THE SURGICEL FOIL NOT SEALED AND EMPTY. NO PRODUCT ENVELOPE OCH SURGICEL FIBRILLAR. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20096683 ↗
• MalfunctionAug 29, 2024Delivered as Unsterile Product; Component Missing; Delivered as Unsterile Product; Component Missing

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE AND AN ABSORBABLE HEMOSTAT WAS USED. WHEN PREPARING FOR OR AND PICKING PRODUCT THE NURSE FOUND THE SURGICEL FOIL NOT SEALED AND EMPTY. NO PRODUCT ENVELOPE OCH SURGICEL FIBRILLAR. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20096675 ↗
• MalfunctionAug 29, 2024Delivered as Unsterile Product; Component Missing; Delivered as Unsterile Product; Component Missing

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE AND AN ABSORBABLE HEMOSTAT WAS USED. WHEN PREPARING FOR OR AND PICKING PRODUCT THE NURSE FOUND THE SURGICEL FOIL NOT SEALED AND EMPTY. NO PRODUCT ENVELOPE OCH SURGICEL FIBRILLAR. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20096659 ↗
• MalfunctionAug 29, 2024Delivered as Unsterile Product; Component Missing; Delivered as Unsterile Product; Component Missing

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE AND AN ABSORBABLE HEMOSTAT WAS USED. WHEN PREPARING FOR OR AND PICKING PRODUCT THE NURSE FOUND THE SURGICEL FOIL NOT SEALED AND EMPTY. NO PRODUCT ENVELOPE OCH SURGICEL FIBRILLAR. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20096597 ↗
• MalfunctionNov 16, 2021Device 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 DEVICE WAS DISPENSED FOR THE PATIENT'S SURGERY AND A HAIR WAS FOUND WHEN OPENING THE DEVICE. THERE WAS NO HARM TO THE PATIENT. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12822360 ↗
• MalfunctionDec 9, 2020Device Markings/Labelling Problem; Device Markings/Labelling Problem

  IT WAS REPORTED THAT AT THE COMPLIANCE CHECKS OF THE PRODUCTS RECEIVED ON 11/10/20 IN THE WAREHOUSE, IT WAS DISCOVERED THAT 2 BOXES OF ABSORBABLE HEMOSTAT, DID NOT BEAR THE EC REP DETAILS. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 10981089 ↗
• MalfunctionDec 9, 2020Device Markings/Labelling Problem; Device Markings/Labelling Problem

  IT WAS REPORTED THAT AT THE COMPLIANCE CHECKS OF THE PRODUCTS RECEIVED ON (B)(6) 2020 IN THE WAREHOUSE, IT WAS DISCOVERED THAT 2 BOXES OF ABSORBABLE HEMOSTAT, DID NOT BEAR THE EC REP DETAILS. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 10981088 ↗