BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN PERMACOL PRODUCT

    MDR report key: 5251342 · Received November 25, 2015

    Report

    Report Number
    9617613-2015-00020
    Event Type
    Injury
    Date Received
    November 25, 2015
    Report Date
    November 25, 2015
    Manufacturer
    COVIDIEN, FORMERLY TISSUE SCIENCE LABOR
    Product Code
    FTM
    PMA / PMN Number
    K120605
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AU
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4) FOR INVESTIGATION OF OTHER REPORTED CASE. (B)(4). AS NO LOT NUMBER WAS PROVIDED, A REVIEW OF THE DEVICE HISTORY RECORD COULD NOT BE PERFORMED. ALL PROCESS AND TEST CRITERIA ARE VERIFIED AS COMPLYING WITH THE FINISHED PRODUCT SPECIFICATIONS FOR ALL RELEASED LOTS. A REVIEW OF HISTORICAL COMPLAINT DATA DISPLAYED NO INCREASE IN TRENDS. SHOULD ADDITIONAL INFORMATION BE RECEIVED, THE RECORD WILL BE REASSESSED AT THAT TIME. LITERATURE REFERENCE: HTTP://WWW.RESEARCHGATE.NET/PROFILE/HEINZ_BACHER/PUBLICATION/266322811_EFFECTIVENESS_OF_PORCINE_DERMAL_COLLAGEN_IN_GIANT_HERNIA_CLOSURE_IN_PATIENTS_WITH_DELETERIOUS_FASCIA_CONSTITUTION_AFTER_ORTHOTOPIC_LIVER_TRANSPLANTATION/LINKS/5444C32F0CF2A76A3CCD8488.PDF

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION RECEIVED FROM THE REPORTER INDICATED THAT, IN HER MEDICAL OPINION, THE COMPLICATION RESULTING FROM THE SURGICAL REPAIR AND IMPLANT WAS A RESULT OF THE PATIENT'S GENERAL CONDITION THAT WAS MARKED BY IMMUNOSUPPRESSIVE REGIMEN, DIABETES AND CONSISTENCY OF THE ABDOMINAL WALL ITSELF. THERE WAS NO ALLEGED RELATIONSHIP BETWEEN THE DEVICE AND THE PATIENT ADVERSE EVENT.

    Description of Event or Problem · 1

    ACCORDING TO THE REPORTER, THE AIM OF THIS STUDY WAS TO EVALUATE THE EFFECTIVENESS OF PORCINE DERMAL COLLAGEN (PDC) FOR THE CLOSURE OF INCISIONAL HERNIAS (IH) AFTER ORTHOTOPIC LIVER TRANSPLANTATION (OLT). PATIENTS WITH A PRIMARY IH GREATER THAN 10CM IN DIAMETER AFTER OLT WERE INCLUDED. 16 PATIENTS RECEIVED THE PDC MESH. "AFTER A PREOPERATIVE SINGLE INJECTION OF 1.5G CEFUROXIME AS ANTIBIOTIC PROPHYLAXIS, THE HERNIA REPAIR WAS PERFORMED WITH A CROSS LINKED PDC MESH PLACEMENT USING BRIDGING TECHNIQUE. THE MESH WAS FIXED USING INTERRUPTED STITCHES WITH MONOFIL FILAMENT. A 14 FRENCH REDON DRAINAGE WAS PLACED ON TOP OF THE MESH. ALL PATIENTS RECEIVED SUBCUTANEOUS INTERRUPTED SUTURES WITH VICRYL 2/0 SUTURES. THE SKIN WAS SUTURED INTRACUTANEOUSLY, AND STERILE DRESSINGS WERE APPLIED. "THE IMMUNOSUPPRESSIVE REGIMEN CONSISTED OF MYCOPHENOLATE MOFETIL (1000MG BID FOR ALL PATIENTS) IN COMBINATION WITH TACROLIMUS (9/16 PATIENTS) OR MTOR (MAMMALIAN TARGET OF RAPAMYCIN) INHIBITORS (7/16 PATIENTS); 1 OF THE 16 PATIENTS RECEIVED 5MG OF PREDNISOLONE DAILY. IN THE CASE OF RECURRENCE AND SUBSEQUENT REOPERATIONS OCCURRING 3-10 MONTHS POST-OPERATIVELY, BIOPSIES OF THE PDC GRAFTS WERE OBTAINED, AND VESSEL INGROWTH WAS MEASURED TO DEPICT THE INTEGRATION OF THE MESH INTO THE PATIENT'S ABDOMINAL WALL. ALL RECURRENCES WERE TREATED SURGICALLY. THERE WERE NO FURTHER SIGNS OF RECURRENCE FOR THE REMAINDER OF THE STUDY. ADDITIONAL INFORMATION HAS BEEN REQUESTED BUT NOT YET RECEIVED. A SUPPLEMENTAL WILL BE SUBMITTED SHOULD ANYTHING FURTHER BE OBTAINED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    780147 UNKNOWN PERMACOL PRODUCT MESH, SURGICAL FTM COVIDIEN, FORMERLY TISSUE SCIENCE LABOR

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention