BEUDAMED
    FDA Adverse Event Death Summary report: N

    PERMACOL

    MDR report key: 599522 · Received May 4, 2005

    Report

    Report Number
    9617613-2005-00014
    Event Type
    Death
    Date Received
    May 4, 2005
    Report Date
    May 3, 2005
    Manufacturer
    TISSUE SCIENCE LABORATORIES PIC,
    Product Code
    FTL
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    THE SURGEON HAD A CASE WHERE PERMACOL WAS SUTURED TO THE PERITONEUM AND THE PATIENTS ABDOMEN WAS CLOSED. THE PATIENT WAS TRANSFERED TO INTENSIVE CARE WHERE THEY HAD TO BE RESPIRATED BY TURNING PATIENT ON THEIR FRONT. AS THEY WAS TURNED, THE WOUND OPENED AND THE PERMACOL WAS EXPOSED. THE PERMACOL TORE AWAY FROM THE SUTURES CAUSING A SMALL BOWEL FISTULA. THE PATIENT LATER DIED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PERMACOL PORCINE DERMAL IMPLANT FTL TISSUE SCIENCE LABORATORIES PIC, UNK UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Death