BEUDAMED
    FDA Adverse Event Other Summary report: N

    PERMACOL

    MDR report key: 667618 · Received January 25, 2006

    Report

    Report Number
    9617613-2006-00001
    Event Type
    Other
    Date Received
    January 25, 2006
    Report Date
    January 24, 2006
    Manufacturer
    TISSUE SCIENCE LABORATORIES, PLC
    Product Code
    FTL
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KY, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    THE SURGEON REPLACED AN INFECTED POLYPROPYLENE MESH USING PERMACOL. INITIALLY THE PT DID WELL BUT AFTER 3-4 WEEKS THE PT DEVELOPED A POST-OPERATIVE WOULD INFECTION. FURTHER INFO WAS RECEIVED IN 06. THE SURGEON PLACED PERMACOL IN A DEFECT THAT WAS APPROX 3-4 INCHES AND DID NOT HAVE ADEQUATE TISSUE FOR SUBSTANTIAL MARGINS. THE SURGEON REMOVED THE DRAINS AFTER SEVERAL DAYS HOWEVER, AT THAT TIME THE DRAIN OUTPUT WAS GRADUALLY INCREASING BUT THE WOUND LOOKED GOOD. THREE TO FOUR WEEKS AFTER SURGERY, THE PT PRESENTED WITH AN INFECTION AND UPON EXPLORATION THE DOCTOR FOUND PERMACOL FRAGMENTS. THERE WAS NO BOWEL EXPOSURE AND THERE WAS A SOFT TISSUE PLATE AND GRANULATION TISSUE WHERE THE PERMACOL HAD BEEN PLACED, ALLOWING THE SURGEON TO PLACE A SKIN GRAFT. THE PT IS CURRENTLY DOING WELL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PERMACOL PORCINE DERMAL IMPLANT FTL TISSUE SCIENCE LABORATORIES, PLC NA 05B21-9

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR Other