BEUDAMED
    FDA Adverse Event Other Summary report: N

    PERMACOL

    MDR report key: 613408 · Received June 10, 2005

    Report

    Report Number
    9617613-2005-00015
    Event Type
    Other
    Date Received
    June 10, 2005
    Report Date
    June 10, 2005
    Manufacturer
    TISSUE SCIENCE LABORATORIES PLC
    Product Code
    FTL
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    THE PATIENT HAD HAD SEVERAL PREVIOUS SURGERIES WITH INSERTION OF A SYNTHETIC MESH TO REPAIR A RECURRENT HERNIA. A 4TH PROCEDURE WAS REQUIRED TO REMOVE AN INFECTED POLY MESH AND AT THIS TIME, PERMACOL WAS IMPLANTED IN THE INFECTED WOUND IN ORDER TO REPAIR THE HERNIA. THE HERNIA RECURRED AND A 5TH PROCEDURE WAS PERFORMED TO EXPLORE THE AREA AND REPAIR THE RECURRENT HERNIA. WHEN THE SURGICAL SITE WAS OPENED UP, IT WAS NOTED THAT THE PERMACOL HAD NEARLY COMPLETELY DISAPPEARED APART FROM A SMALL AMOUNT ON THE PATIENT'S RIGHT HAND SIDE.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 50 YR Other