SURGICEL NU-KNIT 1943Recalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 10705031002975), received between Mar 8, 2019 and Sep 18, 2024 — classified as 6 injuries.

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 6 most recent of 6 reports, in the reporter's own words as published by the FDA.

• InjurySep 18, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT A COLECTOMY PROCEDURE ON AN UNKNOWN DATE FIBRIN SEALANT WAS USED. TWO PATIENTS IN A LAP COLECTOMY PROCEDURE THAT THE FIBRIN SEALANT WAS USED ON LIVER BED FOR BLEEDING, BUT THE PATIENT HAD GOTTEN ABSCESS THAT NEEDED TO BE DRAINED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: Abscess

  MAUDE report 20245795 ↗
• InjuryJul 30, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED VIA A JOURNAL ARTICLE: A RARE CASE OF POSTOPERATIVE SYMPTOMATIC CYST FORMATION AFTER RESECTION OF A LARGE CONVEXITY MENINGIOMA TAKESHI FUJIMORI, ATSUSHI SHINDO, DAISUKE OGAWA, MASAKI OKADA, TETSUHIRO HATAKEYAMA, MASANOBU OKAUCHI, MASAHIKO KAWANISHI, KEISUKE MIYAKE, TAKASHI TAMIYA WORLD NEUROSURG. (2019) 127:160-164. BACKGROUND: SYMPTOMATIC CYST FORMATION AFTER BRAIN TUMOR RESECTION IS A RARE COMPLICATION OF THE EARLY POSTOPERATIVE PHASE. WE DESCRIBE A COMPLICATED CASE OF POSTOPERATIVE SYMPTOMATIC CYST FORMATION AFTER GROSS TOTAL REMOVAL OF A CONVEXITY MENINGIOMA. CASE DESCRIPTION: A (B)(6) YEAR-OLD WOMAN PRESENTED WITH RECENT ONSET MOTOR APHASIA. MAGNETIC RESONANCE IMAGING REVEALED A LEFT CONVEXITY TUMOR. WE PERFORMED GROSS TOTAL RESECTION OF THE TUMOR, WHICH WAS PATHOLOGICALLY DIAGNOSED AS AN ATYPICAL MENINGIOMA. AN ABSORBABLE HEMOSTAT WAS PLACED OVER THE SURFACE OF THE TUMOR CAVITY. TUMOR RESECTION AND DECOMPRESSION OF THE NORMAL CEREBRAL HEMISPHERE IMPROVED APHASIA. HOWEVER, 3 DAYS AFTER SURGERY, HER MOTOR APHASIA WORSENED. COMPUTED TOMOGRAPHY SCAN CONFIRMED THAT THE FRONTAL LOBE WAS BEING COMPRESSED BY AN ENLARGEMENT OF THE POSTOPERATIVE TUMOR CAVITY. CONSERVATI

  Patient problems: Cyst(s)

  MAUDE report 8842486 ↗
• InjuryJun 7, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT A LAPAROSCOPIC CHOLECYSTECTOMY PROCEDURE ON (B)(6) 2019 AND AN ABSORBABLE HEMOSTATIC DEVICE WAS USED ON THE LIVER BED FOR OOZING AND HEMOSTASIS WAS DONE. THE PATIENT HAD CHOLANGITIS BEFORE THE OPERATION, SO A HIGH FEVER CONTINUED AFTER THE OPERATION, AND A TUMOR LESION INCLUDING A SMALL AMOUNT OF GAS ACCUMULATION ON THE LOWER SURFACE OF THE LIVER WAS FOUND BY CT. A PERCUTANEOUS TRANSHEPATIC DRAIN WAS PLACED ON THE SITE. THE DRAINAGE WAS NOT OBVIOUS PUS, BUT PSEUDOMONAS AERUGINOSA AND ENTEROCOCCI WERE DETECTED FROM THE DRAINAGE, SO ANTIMICROBIALS WERE USED THAT SHOW SENSITIVITY TO EACH MICROBE. CLEANING USING THE DRAIN IS CONTINUING, BUT IT HAS BEEN DIFFICULTY TO CONTROL THE INFECTION EVEN AFTER MORE THAN ONE MONTH. IT IS PRESUMED THAT THE PRODUCT AND HEMATOMA FORMED A BIOFILM IN A STATE OF BEING ORGANIZED AND FORMED INTO A MASS.

  Patient problems: Anemia; Hematoma; No Code Available; Unspecified Infection

  MAUDE report 8678806 ↗
• InjuryMar 11, 2019Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT A THYROIDECTOMY PROCEDURE ON AN UNKNOWN DATE IN EARLY (B)(6) 2019 AND ABSORBABLE HEMOSTAT DEVICE WAS USED. THE ABSORBABLE HEMOSTAT DEVICE WAS CUT INTO A STAMP SIZE AND PLACED IN THE OPERATION SITE BEFORE WOUND CLOSURE. THE PATIENT EXPERIENCED A POST OP INFECTION. ON POST-OP DAY 6, THE PATIENT SUFFERED FROM FEVER, REDNESS AND PUS LEAKAGE. THE WOUND WAS THEN EXPLORED FOR DRAINAGE. THE PATIENT WAS KEPT IN THE HOSPITAL FOR MORE THAN TWO WEEKS FOR DRESSING WITH TREATMENT BY ANTIBIOTICS. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: Erythema; Fever; Purulent Discharge; Unspecified Infection

  MAUDE report 8410654 ↗
• InjuryMar 11, 2019Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT A THYROIDECTOMY PROCEDURE ON AN UNKNOWN DATE IN (B)(6) 2018 AND ABSORBABLE HEMOSTAT DEVICE WAS USED. THE ABSORBABLE HEMOSTAT DEVICE WAS CUT INTO A STAMP SIZE AND PLACED IN THE OPERATION SITE BEFORE WOUND CLOSURE. THE PATIENT EXPERIENCED A POST OP INFECTION. ON (B)(6) 2019, SWELLING AND REDNESS WERE OBSERVED IN THE WOUND SITE. ON (B)(6) 2019, THERE WAS LEAKAGE OF PUS FROM THE WOUND. THE WOUND WAS THEN EXPLORED FOR DRAINAGE. THE PATIENT WAS KEPT IN THE HOSPITAL FOR MORE THAN TWO WEEKS FOR DRESSING WITH TREATMENT BY ANTIBIOTICS. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: Erythema; No Code Available; Purulent Discharge; Unspecified Infection

  MAUDE report 8409838 ↗
• InjuryMar 8, 2019Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT A THYROIDECTOMY PROCEDURE ON AN UNKNOWN DATE IN (B)(6) 2018 AND ABSORBABLE HEMOSTAT DEVICE WAS USED. THE PATIENT HAD GRAVES' DISEASE. THE ABSORBABLE HEMOSTAT DEVICE WAS CUT INTO A STAMP SIZE AND PLACED IN THE OPERATION SITE BEFORE WOUND CLOSURE. THE PATIENT EXPERIENCED A POST OP INFECTION. ON POST-OP DAY 1, THE PATIENT SUFFERED FROM HIGH FEVER WITH NECK REDNESS AND SWELLING. THE PATIENT WAS TREATED WITH ASPIRATION OF PUS. ON POST-OP DAY 2, THE WOUND WAS EXPLORED WITH DRAINAGE OF 50ML PUS. THE PATIENT WAS KEPT IN THE HOSPITAL FOR MORE THAN TWO WEEKS FOR DRESSING WITH TREATMENT BY ANTIBIOTICS. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: Erythema; Fever; No Code Available; Not Applicable; Purulent Discharge; Unspecified Infection

  MAUDE report 8406054 ↗