BEUDAMED
    FDA Adverse Event Other Summary report: N

    PERMACOL

    MDR report key: 648739 · Received November 30, 2005

    Report

    Report Number
    9617613-2005-00035
    Event Type
    Other
    Date Received
    November 30, 2005
    Report Date
    November 29, 2005
    Manufacturer
    TISSUE SCIENCE LABORATORIES, PLC
    Product Code
    FTL
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    THE PT HAD A HERNIA REPAIR IN 2004 AND PERMACOL WAS IMPLANTED. DURING THE INITIAL PROCEDURE, THE SKIN WAS DISSECTED TO DEMONSTRATE THE HERNIA AND IT WAS ESTABLISHED THAT THE MUSCLE/FASCIA WAS TOO WEAK TO BE BROUGHT TO THE MIDLINE. PERMACOL WAS PLACED IN THE WOUND AND SUTURED TO THE EDGES BEHIND THE FASCIAL DEFECT. A YEAR AFTER THE REPAIR THE HERNIA BEGAN TO BULGE. THIS BECAME PROGRESSIVELY WORSE AND THE PT HAD A SECOND PROCEDURE TO REPAIR THE RECURRENT HERNIA IN 2005.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR Other