BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PERMACOL

    MDR report key: 1083451 · Received July 29, 2008

    Report

    Report Number
    9617613-2008-00008
    Event Type
    Injury
    Date Received
    July 29, 2008
    Report Date
    July 29, 2008
    Manufacturer
    TISSUE SCIENCE LABORATORIES, PLC
    Product Code
    FTL
    PMA / PMN Number
    K992556
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    FURTHER INFO ON THE EVENT HAS BEEN REQUESTED FROM THE PHYSICIAN. IF NEW INFO BECOMES AVAILABLE, A FOLLOW-UP REPORT WILL BE FILED. THE PRODUCT IS MFG USING A CONTROLLED AND VALIDATED MFG PROCESS. THE PRODUCT IS TERMINALLY STERILIZED BY IRRADIATION AND HAS UNDERGONE STERILIZATION VALIDATION AND DOSE AUDIT STUDIES IN ACCORDANCE WITH ISO 11137. ROUTINE PRODUCT BIOBURDEN MONITORING IS PERFORMED TO HELP SAFEGUARD STERILITY ASSURANCE. PRODUCT AND PACKAGING INSPECTION STAGES HAVE BEEN IMPLEMENTED IN CONJUNCTION WITH A VALIDATED PROCESS AND DOCUMENTED SYSTEMS TO HELP SAFEGUARD AND ASSURE PRODUCT QUALITY. FOLLOWING A REVIEW OF THE DEVICE HISTORY RECORD FOR ALL PROCESS AND TEST CRITERIA HAS BEEN VERIFIED, AS COMPLYING WITH THE PERMACOL FINISHED PRODUCT SPECIFICATION. THE INVESTIGATION CONCLUDED SATISFACTORY PROCESSING AND PACKAGING OF TISSUE AND RESULTANT TESTING OF PRODUCT. NO EVIDENCE TO SUGGEST ANY REASON FOR POTENTIAL PRODUCT ABSORPTION, STERILITY OR TENSILE CONCERNS. CHEMICALS, EQUIPMENT, PROCESS DURATION AND PROCESS, TEMPERATURES HAVE BEEN VERIFIED AS SATISFACTORY.

    Description of Event or Problem · 1

    PT AT HOSP, USED A 20X30 PIECE OF PERMACOL. THE PT IS QUESTION WAS HAVING A LARGE INCISIONAL HERNIA REPAIR, FOLLOWING A REMOVAL OF A COMPOSIX MESH, WHICH WAS INFECTED. THE PT'S HISTORY IS AS FOLLOWS - THE ORIGINAL OPERATION WAS FOR PERFORATED DIVERICULAR DISEASE, THEN AN OPERATION FOR A REVERSAL OF A HARTMANN'S, THEN A LARGE INCISIONAL HERNIA REPAIR, THEN A MESH REPAIR (COMPOSIX), THEN THE INFECTED MESH REMOVAL WITH PERMACOL BEING PUT IN SITU. THE PT HAD MRSA AND WHEN LATER TESTED, WAS SHOWN TO HAVE OTHER INFECTIONS AS WELL, INCLUDING PSEUDOMONOUS. THE PT HAD NO OTHER CO-MORBIDITIES. DURING THE OPERATION, PT WAS UNABLE TO REMOVE ALL OF THE SYNTHETIC MESH, SO A SMALL AMOUNT OF THIS WAS LEFT INSIDE THE PT AND SITTING NEXT TO THE PERMACOL. WHEN THE PT PRESENTED WITH COMPLICATIONS, THEY WENT BACK IN TO THEATRE TO REMOVE THE PERMACOL, AND IT WAS STUCK TO THE BOWEL WITH AN ABCESS UNDERNEATH ON THE OTHER SIDE TO WHERE THE OLD MESH WAS SITUATED. THE SURGEON CONSIDERS PERMACOL IS IN NO WAY TO BLAME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PERMACOL PORCINE DERMAL IMPLANT FTL TISSUE SCIENCE LABORATORIES, PLC NA 07B12-6

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Required Intervention