BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    1 CHROMIC GUT/ON/T - 25

    MDR report key: 109535 · Received July 8, 1997

    Report

    Report Number
    109535
    Event Type
    Malfunction
    Date Received
    July 8, 1997
    Date of Event
    April 21, 1997
    Report Date
    April 21, 1997
    Manufacturer
    *
    Product Code
    GAL
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    OH, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    TAH, BILATERAL URETERAL CATH INSERTION, LSO APPENDECTOMY WAS PERFORMED. DURING THE PROCEDURE, THE SUTURES CONTINUED TO BREAK AND FRAY, WHILE THE DR TRIED TO TIE OFF BLEEDERS. A DIFFERENT TYPE OF SUTURE WAS USED SUCCESSFULLY. THERE WAS AN EXTENDED OR TIME AS A RESULT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 1 CHROMIC GUT/ON/T - 25 Implant GENERAL CLOSURE SUTURE GAL * 546-73 941391

    Patients

    Seq Age Sex Outcome Treatment
    1 44 YR Other