BEUDAMED
    FDA Adverse Event Other Summary report: N

    PERMACOL

    MDR report key: 540925 · Received August 27, 2004

    Report

    Report Number
    9617613-2004-00006
    Event Type
    Other
    Date Received
    August 27, 2004
    Date of Event
    May 7, 2004
    Report Date
    August 13, 2004
    Manufacturer
    TISSUE SCIENCE LABORATORIES PLC,
    Product Code
    FTL
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NV, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    THE PT HAD A FAILED GASTRIC BYPASS AND A LARGE TISSUE DEFECT. THE SURGEON USED AN 18X28 AND 15X20 PIECE OF PERMACOL. THE SURGEON DID A SMALL BOWEL RESECTION DUE TO THE ABDUNDANCE OF ORGANS TO PLACE BACK IN THE CAVITY. THE PT HAD A CONTAMINATED WOUND. POST OP THE PT HAD A TANISH COLOUR COMING OUT OF THE DRAIN. THE PT DEVELOPED AN OPEN TISSUE WOUND MORE AT THE EPIDERMAL LAYER. THE SURGEON CURRENTLY THINKS THE PT HAS RE-HERNIATED, AND THINKS THE PERMACOL HAS "GONE AWAY." REPORTED DOING A CULTURE WHICH GREW ANAEROBES. BARIATRIC SURGERY FAILURE, RESECTION OF THE BOWEL. REMOVAL OF RIGHT COLON AND LOSS OF ABDOMINAL DOMAIN. THE PERMACOL TISSUE APPARENTLY DISSOLVED IN THE PRESENCE OF BROWN EXUDATES. THE SURGEON USED VYVOX FOR A FEW DAYS AND SAW A DECREASE IN DRAINAGE. THE SURGEON DID NOT KEEP THE PT ON LONG-TERM ANTIBIOTICS. THE PT HAS AN OPEN WOUND AT PRESENT WITH THE BOWEL EXPOSED. THERE WAS SUCH LOSS OF THE ABDOMINAL WALL THAT SOME OF THE BOWEL WAS REMOVED IN AN ATTEMPT TO PUT BACK INTO THE ABDOMEN. THE SURGEON STATES HE WILL HAVE TO REPAIR THE RECURRENT HERNIA AND ABDOMINAL WALL. THE SURGEON STATED THAT HE SHOULD HAVE BEEN MORE AGGRESSIVE WITH ANTIBIOTIC COVERAGE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PERMACOL PORCINE DERMAL IMPLANT FTL TISSUE SCIENCE LABORATORIES PLC, NA 03B18-2

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Hospitalization| O