BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TENSION FREE VAGINAL TAPE

    MDR report key: 1040151 · Received May 9, 2008

    Report

    Report Number
    2210968-2008-00336
    Event Type
    Injury
    Date Received
    May 9, 2008
    Date of Event
    March 1, 2008
    Report Date
    April 8, 2008
    Manufacturer
    ETHICON, INC.
    Product Code
    FTL
    PMA / PMN Number
    K052401
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DATE SENT TO THE FDA: 05/08/2008. VAGINAL BUTTON HOLE OCCURRED - MESH EXPOSURE OCCURRED - MESH EXPOSURE OCCURRED - CONCLUSION: NO CONCLUSION CAN BE DRAWN AT THIS TIME. SHOULD ADD'L INFO BE OBTAINED, A SUPPLEMENTAL 3500A FORM WILL BE SUBMITTED ACCORDINGLY. A REVIEW OF THE BATCH MANUFACTURING RECORDS WAS CONDUCTED AND THE BATCH MET ALL FINISHED GOODS RELEASE CRITERIA.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PT UNDERWENT A SLING PROCEDURE IN 2008. DURING THE PROCEDURE, A SMALL BUTTON HOLE WS NOTED ON THE LEFT SIDE. THE SURGEON RECOGNIZED IT AND REPAIRED IT. AT THE PT'S THREE AND ONE-HALF WEEK POST-OPERATIVE VISIT, THE MESH WAS FOUND EXPOSED AT THE SITE OF THE PREVIOUS BUTTON HOLE. THE EXPOSURE WAS LOCATED AT THE MIDLINE AND MEASURED ONE AND THREE-QUARTER CENTIMETERS. THE SURGEON PROPOSES RESECTING THE EXPOSED PORTION OF TAPE, FREEING, UP AND FRESHENING THE VAGINAL EDGES, AND THEN RE-CLOSING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TENSION FREE VAGINAL TAPE MESH, SURGICAL, POLYMERIC FTL ETHICON, INC. NA 3065831

    Patients

    Seq Age Sex Outcome Treatment
    1 46 YR Required Intervention