BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TIMESH

    MDR report key: 1422954 · Received July 27, 2009

    Report

    Report Number
    3003936139-2009-00003
    Event Type
    Injury
    Date Received
    July 27, 2009
    Report Date
    July 27, 2009
    Manufacturer
    GFE MEDIZINTECHNIK GMBH
    Product Code
    FTL
    PMA / PMN Number
    K031225
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    IT WAS RECENTLY DISCOVERED THAT THIS CASE HAS NOT BEEN APPROPRIATELY REPORTED. A REVIEW OF THE BATCH MANUFACTURING RECORDS WAS CONDUCTED IMMEDIATELY AFTER RECEIPT OF THE MESSAGE (DATED 2007); THE BATCH MET ALL CRITERIA FOR THE RELEASE OF FINISHED PRODUCTS. A SECOND REVIEW OF THE DHR AND RETAINED SAMPLES WERE CARRIED OUT PRIOR TO THIS MDE (SEE ANNEX 1 AND 2). CONCLUSION CODE: NO CONCLUSION CAN BE DRAWN AT THIS TIME. SHOULD ADDITIONAL INFORMATION BE OBTAINED, A SUPPLEMENTAL FORM WILL BE SUBMITTED ACCORDINGLY.

    Description of Event or Problem · 1

    INFORMATION RECEIVED: PROCEDURE: THE BOWEL WAS REPLACED BACK INTO THE ABDOMINAL CAVITY USING A PIECE OF 4 X 6 INCH TI MESH. IT WAS SUTURED AT THE SUPERIOR ASPECT AND GOING TO THE MEDIAL AND LATERAL ASPECT. IT WAS SPLIT AROUND THE ILEAL CONDUIT AND THEN A HOLE WAS MADE IN THE MESH TO ALLOW THE CONDUIT TO LIE COMFORTABLY AND IT WAS CLOSED BEHIND THIS DEEP AND THEN ATTACHED THE FASCIA IN THIS MANNER. THIS WAS ALL DONE USING INTERRUPTED 2 ETHIBOND SUTURE. THE PATIENT HAD ENOUGH ROOM FOR ILEAL CONDUIT. OUTCOME: - 40 CM OF BOWEL HAD TO BE REMOVED - MESH ENTWINED WITHIN BOWEL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TIMESH SURGICAL MESH, FTL FTL GFE MEDIZINTECHNIK GMBH 6000138 10457

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization