BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TENSION FREE VAGINAL TAPE

    MDR report key: 1141054 · Received August 29, 2008

    Report

    Report Number
    2210968-2008-00732
    Event Type
    Injury
    Date Received
    August 29, 2008
    Date of Event
    January 23, 2008
    Report Date
    July 29, 2008
    Manufacturer
    ETHICON, INC.
    Product Code
    FTL
    PMA / PMN Number
    K052401
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DATE SENT TO THE FDA: 08/28/2008. MESH TORN - CONCLUSION: NO CONCLUSION CAN BE DRAWN AT THIS TIME. SHOULD ADD'L INFO BE OBTAINED, A SUPPLEMENTAL 3500A FORM WILL BE SUBMITTED ACCORDINGLY. IN ADDITION, A REVIEW OF THE BATCH MFG RECORDS WAS CONDUCTED AND THE BATCH MET ALL FINISHED GOOD RELEASE CRITERIA.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PT UNDERWENT A SLING PROCEDURE IN THE HAMMOCK POSITION IN 2008. DURING INSERTION OF THE DEVICE, THE RIGHT SIDE OF THE MESH BROKE. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH A DIFFERENT TYPE OF SLING DEVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TENSION FREE VAGINAL TAPE MESH, SURGICAL, POLYMERIC FTL ETHICON, INC. NA 2998103

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Required Intervention