SURGICEL SNoW 2081Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 10705031063587), received between Jan 24, 2018 and Apr 9, 2024 — classified as 4 injuries, 1 malfunction.

The most frequently reported specific device problem is “Device Markings/Labelling Problem” (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. How this data works · Data updated Oct 13, 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.

• MalfunctionApr 9, 2024Device Markings/Labelling Problem; Device Markings/Labelling Problem

  IT WAS REPORTED THAT PRIOR TO AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE THE HOSPITAL WAREHOUSE STAFF FOUND THE ABSORBABLE HEMOSTAT FIRST BARCODE NUMBER AFTER (01) FOR OUTER PACKAGE WAS ¿2¿, BUT THE FIRST BARCODE NUMBER AFTER (01) FOR INNER PACKAGE WAS¿1¿, THEY ARE DIFFERENT. NO PRODUCT ISSUE OR PATIENT CONSEQUENCE WAS FOUND. ADDITIONAL INFORMATION WAS REQUESTED

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19075925 ↗
• InjuryJan 18, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A 50 YEAR OLD PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE WHERE ABSORBABLE HEMOSTAT WAS USED. AFTER INTRAOPERATIVE HEMOSTASIS, THE SURGICAL WOUND WAS COVERED WITH, AND A RAPID INCREASE IN HEART RATE OCCURRED, WITH A MAXIMUM OF 155 BEATS PER MINUTE. BLOOD PRESSURE DROPPED TO 60/40, AND THE PATIENT'S ARMS AND FACE WERE FOUND TO HAVE PAPULES AND REDNESS. IT WAS SUSPECTED THAT THE ABSORBABLE HEMOSTAT TRIGGERED AN ALLERGIC REACTION. IMMEDIATELY, THE ABSORBABLE HEMOSTAT MATERIAL WAS REMOVED THROUGH LAPAROTOMY AND STERILIZED WITH WATER. AFTER WASHING WITH WATER, THE HEART RATE AND BLOOD PRESSURE RETURNED TO NORMAL. AFTER SURGERY, THE PATIENT WAS SENT TO THE ICU FOR OBSERVATION. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: High Blood Pressure/ Hypertension; Hypersensitivity/Allergic reaction; Inflammation; Low Blood Pressure/ Hypotension; Skin Inflammation/ Irritation

  MAUDE report 18539744 ↗
• InjuryJan 31, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT A LAPAROSCOPIC THYROID LOBECTOMY/PARA THYROID PROCEDURE ON (B)(6) 2019 AND AN ABSORBABLE HEMOSTAT WAS USED. POST OPERATIVELY, THE PATIENT HAD AN ALLERGIC REACTION. AT THE CONCLUSION OF THE PROCEDURE THE SURGEON APPLIED THE ABSORBABLE HEMOSTAT AT .025% BUPIVACAINE WITH PHRINE. WITH IN A FEW MINUTES THE PATIENT WAS NOTED AS HAVING ERYTHEMA ALL AROUND THE INCISION SITE APPROXIMATELY TEN CENTIMETERS IN ALL DIRECTIONS. NO ERYTHEMA WAS NOTED PRIOR TO APPLYING THE ABSORBABLE HEMOSTAT. THE PATIENT WAS TREATED WITH ORAL AND TOPICAL STEROIDS, IN ADDITION TO BENADRYL. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: Hypersensitivity/Allergic reaction

  MAUDE report 9650774 ↗
• InjuryNov 21, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED BY THE PATIENT THAT SHE HAD A C-SECTION ON (B)(6) 2019 AND AN ABSORBABLE HEMOSTAT WAS USED TO STOP THE BLEEDING OVER HER UTERUS AND BLADDER. SINCE HER PROCEDURE SHE DOES NOT HAVE THE URGE TO URINATE. HER PHYSICIAN TOLD HER THAT NONE OF THE NERVES WERE CUT. PATIENT INDICATED THAT SHE CAN URINATE BUT THERE IS NO URGE. SHE CAN HOWEVER FEEL WHEN SHE DOES URINATE. SHE ALSO HAS ISSUES DRIPPING SINCE THE C-SECTION. THAT WASN'T A PROBLEM BEFORE. SHE HAS DISCUSSED THE ISSUE WITH HER O.B. TO DETERMINE IF THE SYMPTOMS SHE IS HAVING IS COMMON AFTER USING THIS PRODUCT. NO ADDITIONAL INFORMATION WAS PROVIDED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: Hypoesthesia

  MAUDE report 9354272 ↗
• InjuryJan 24, 2018Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  IT WAS REPORTED THAT THE PATIENT UNDERWENT AN ENDOMETRIOSIS PROCEDURE ON AN UNKNOWN DATE, AND ABSORBABLE HEMOSTAT WAS USED. AFTER DISCHARGE, THE PATIENT EXPERIENCED FEVER AND VOMITED. THE PHYSICIAN OPINES THAT SEMI FLUID SEEN IN ULTRASOUND MAY HAVE LED TO THE VOMITING. THE PATIENT UNDERWENT A RE-OPERATION. THE PHYSICIAN OPINES THAT THE CONTRIBUTING FACTORS TO THE REACTION MAY BE BECAUSE OF INFECTION OR USE OF OTHER HEMOSTAT. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: Fever; Not Applicable; Vomiting

  MAUDE report 7216984 ↗