BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PERMACOL 20X30 1.5MM

    MDR report key: 3853557 · Received June 3, 2014

    Report

    Report Number
    9617613-2014-00106
    Event Type
    Injury
    Date Received
    June 3, 2014
    Date of Event
    January 18, 2014
    Report Date
    May 21, 2014
    Manufacturer
    COVIDIEN, FORMERLY TISSUE SCIENCE LABORATORIES, PLC
    Product Code
    FTL
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MX
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    THE PHYSICIAN INDICATES: PATIENT MALE, (B)(6), HE TOOK ALONG WITH UROLOGY SURGERY FOR A RADICAL CYSTECTOMY, RESECTION OF THE URACHUS AND THE CONSTRUCTION OF AN ILEAL CONDUIT DER FLANK. SUCCESSFULLY EVOLVED FROM SURGERY, THE SEVENTH POSTOPERATIVE DAY, THE PATIENT RECEIVED TREATMENT FOR ASSISTANCE MISTAKENLY COUGH. CAUSING THIS A HERNIA WOUND WHY IT TOOK SURGERY, TISSUES WERE FOUND IN POOR CONDITION, HE PROCEEDED TO MAKE LAYERED CLOSURE AGAIN FOUR DAYS LATER THE PATIENT AFTER GOING SUCCESSFULLY EVOLVE ON EXERTION AGAIN HAS A HERNIA SO AGAIN IS TAKEN TO THE OPERATING ROOM WITH THE IDEA OF PLACING A MESH. HOWEVER TO EXPLORE, THE PATIENT FOUND THE WALL IN POOR CONDITION LIKEWISE FIND A COLLECTION WHICH WAS DRAINED AND THE PRESENCE OF A STOMA, SO IT WAS DECIDED TO PLACE A BIOLOGIC MESH TYPE PERMACOL APPROXIMATELY 25 BY 30 INCHES. THE PATIENT TOLERATED THE PROCEDURE IS APPROXIMATELY APPROPRIATELY RATED 4 MONTHS POSTOPERATIVE. THE PATIENT INITIALLY PRESENTED FROM A HOLE ABOUT 3 MM IN THE DISTAL THIRD OF THE WOULD WHICH INITIALLY DRAINED MATERIAL, YELLOW AND WITHOUT PRESENTING COFFEE ODOR. FOR ABOUT A MONTH THE PATIENT STOPPED DRAINING, CLOSING THIS HOLE. A MONTH AGO, THE PATIENT HAD AN INTESTINAL OBSTRUCTION THAT REQUIRED HOSPITAL MANAGEMENT WHERE WE DID A CT FINDING MINIMAL SPACE BELOW PX WOULD AND MESH PERFECTLY WELL PLACED. HOWEVER, THE PATIENT BACK HOME WITH DRAINAGE DRAINING THE SITE ABOVE, CHANGING THE CHARACTERISTICS OF THE DRAINAGE TO A RICH GREEN AND SMELLY DRAIN WHICH SENT REPORTING A ENTEROCOCCUS CULTURE WHICH WAS MANAGED WITH ANTIBIOTICS, THE PATIENT CONTINUES TO DRAIN HAS BEEN ADDED OUTPUT COMPATIBLE MATERIAL WITH MESH FRAGMENTS WHICH WE HAVE SEEN AND PHOTOGRAPHED AT THE CLINIC. THE LATEST DEVELOPMENT CULTURE AN E. COLI.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    323705 PERMACOL 20X30 1.5MM PERMACOL FTL COVIDIEN, FORMERLY TISSUE SCIENCE LABORATORIES, PLC UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR