BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PERMACOL

    MDR report key: 440381 · Received January 31, 2003

    Report

    Report Number
    440381
    Event Type
    Injury
    Date Received
    January 31, 2003
    Date of Event
    January 27, 2003
    Report Date
    January 28, 2003
    Manufacturer
    TSL PLC
    Product Code
    FTM
    Report Source
    User Facility report
    Reporter Location
    OH, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    PERMACOL SOFT TISSUE IMPLANT USED IN ABDOMEN. ALL SUTURES TORE OUT THROUGH THE PERMACOL REMAINING IN THE FASCIA. THIS RESULTED IN MORE SURGERY TO REMOVE FREE FLOATING IMPLANT AND REPLACEMENT WITH ANOTHER PRODUCT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PERMACOL SOFT TISSUE IMPLANT FTM TSL PLC * *

    Patients

    Seq Age Sex Outcome Treatment
    1 51 YR Hospitalization