BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TIMESH

    MDR report key: 1422947 · Received July 27, 2009

    Report

    Report Number
    3003936139-2009-00001
    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 10-24-2007); THE BATCH MET ALL CRITERIA FOR THE RELEASE OF FINISHED PRODUCTS. AN ADDITIONAL TEST OF THE MECHANICAL STRENGTH OF THE MESH MEASURED ON RETAINED SAMPLE EXCEEDED SPECIFICATION. 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. SEE SCANNED PAGES.

    Description of Event or Problem · 1

    INFORMATION RECEIVED: PROCEDURE: USING TWO 10 X 15 CM TIE MESH PROSTHETICS, WHICH WERE 35 G PER METERS SQUARED, THE MESH WAS TACKED ONTO THE ABDOMINAL WALL, COMPLETELY ENCOMPASSING THE HERNIA WITH APPROXIMATELY A 3 CM MARGIN AROUND THE HERNIA. THE TACKS WERE PLACED AT 1 CM INTERVALS. OUTCOME: WEAKNESS MESH DID NOT ADHERE. IMMEDIATELY, THE RIGHT LOWER QUADRANT WAS INSPECTED AND A DENSE ADHESION WAS SEEN WITH SMALL BOWEL AND OMENTUM ATTACHED TO THE TIMESH. THE LOWER LEFT QUADRANT WAS COMPLETELY FREE. ONCE ALL THE ADHESIONS WERE TAKEN DOWN, IT APPEARED THAT THE MEDIAL ASPECT OF THE REPAIR SHOWED A WEAKNESS WITH THE MESH AT THE EDGE OF THE FASCIA DEFECT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TIMESH SURGICAL MESH, FTL FTL GFE MEDIZINTECHNIK GMBH 6000138 10453

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization