BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PERMACOL

    MDR report key: 1021316 · Received March 27, 2008

    Report

    Report Number
    9617613-2008-00004
    Event Type
    Injury
    Date Received
    March 27, 2008
    Report Date
    March 28, 2008
    Manufacturer
    TISSUE SCIENCE LABORATORIES PLC
    Product Code
    FTL
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    TO DATE, NO LOT NUMBER INFORMATION HAS BEEN PROVIDED. HOWEVER, TSL CAN CONFIRM THAT THE PRODUCT IS MANUFACTURED USING A CONTROLLED AND VALIDATED MANUFACTURING 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. TSL REQUESTED ADDITIONAL INFORMATION FROM THE SURGEON. HOWEVER, TO DATE NO FURTHER INFORMATION HAS BEEN RECEIVED.

    Description of Event or Problem · 1

    IN EARLY 2004, THE PATIENT DEVELOPED SEVERAL PAINFUL ABSCESSES ON HIS SIDE AND AN INFECTED ABSCESS ON HIS STOMACH AS A RESULT OF GALLSTONES, WHICH REMAINED IN HIS BODY FOLLOWING GALLBLADDER SURGERY IN 2002. THE INFECTED STOMACH ABSCESS WAS REMOVED, RESULTING IN A 4.5 INCH LONG, 2 INCH WIDE WOUND LEFT OPEN DUE TO INFECTION. IN SUMMER 2004, THE PATIENT WAS DIAGNOSED WITH A SMALL, BUT GROWING HERNIA NEAR THE SITE OF THE PATIENT'S HEALING STOMACH WOUND. IN NOVEMBER 2004, THE PATIENT HAD THE HERNIA REPAIRED AND PERMACOL IMPLANTED TO REPAIR THE DAMAGED SOFT TISSUE. IN MARCH 2005, THE PATIENT LEARNED THAT ADDITIONAL SURGERY WOULD BE NECESSARY TO ADDRESS THE RECURRENCE OF A HERNIA. BECAUSE OF CONTINUING GALL STONE PROBLEMS, THE PATIENT'S FOLLOW-UP SURGERY COULD NOT BE SCHEDULED UNTIL 2006, ON WHICH DATE THE SURGEON PERFORMED A SECOND SURGERY. THE SURGERY REVEALED NO TRACE OF THE PREVIOUSLY IMPLANTED PERMACOL, WHICH HAD ALLEGEDLY DISSOLVED IN THE PATIENT'S ABDOMEN.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Other