BEUDAMED
    FDA Adverse Event Other Summary report: N

    PERMACOL

    MDR report key: 652823 · Received December 12, 2005

    Report

    Report Number
    9617613-2005-00038
    Event Type
    Other
    Date Received
    December 12, 2005
    Report Date
    December 12, 2005
    Manufacturer
    TISSUE SCIENCE LABORATORIES, PLC
    Product Code
    FJL
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    PERMACOL WAS IMPLANTED IN A LARGE ABDOMINAL WALL RECONSTRUCTION. SUBSEQUENTLY THE SKIN AROUND THE SUTURE LINE BROKE DOWN AND LEFT PART OF THE LARGE PIECE OF PERMACOL EXPOSED. THE DR DECIDED TO USE WET DRESSING AND A WOUND VAC TO MANAGE THE SITUATION. INITIALLY THE PERMACOL WAS HOLDING UP WELL AND GRANULATION TISSUE BEGAN TO APPEAR. TWELVE DAYS LATER THE DR REPORTED THAT THE PERMACOL BROKE DOWN AND STATED THAT SECONDARY INFECTION COULD BE AT WORK.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Hospitalization| O