BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TENSION FREE VAGINAL TAPE

    MDR report key: 1081580 · Received July 24, 2008

    Report

    Report Number
    2210968-2008-00592
    Event Type
    Injury
    Date Received
    July 24, 2008
    Date of Event
    March 11, 2008
    Report Date
    June 23, 2008
    Manufacturer
    ETHICON, INC.
    Product Code
    FTL
    PMA / PMN Number
    K974098
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CONCLUSION: NO CONCLUSION CAN BE DRAWN AT THIS TIME. SHOULD ADDITIONAL 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 LATE 2007. THE PT HAD A NORMAL VOIDING PATTERN UPON DISCHARGE. POST-OPERATIVELY, THE PT EXPERIENCED A VAGINAL EROSION OF THE DEVICE. AS A RESULT, IN 2008, THE PT WAS PLACED UNDER GENERAL ANESTHESIA AND THE DEVICE WAS TRIMMED AND THE VAGINA WAS CLOSED. THE PT DEVELOPED MIXED INCONTINENCE AFTER TRIMMING OF THE ERODED DEVICE AND CLOSURE OF THE VAGINA. THE PT IS SCHEDULED TO HAVE URODYNAMICS DONE ON APPROX TWO MONTHS LATER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TENSION FREE VAGINAL TAPE MESH, SURGICAL, POLYMERIC FTL ETHICON, INC. NA 3046819

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention