BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TENSION FREE VAGINAL TAPE

    MDR report key: 1241603 · Received November 20, 2008

    Report

    Report Number
    2210968-2008-01143
    Event Type
    Injury
    Date Received
    November 20, 2008
    Date of Event
    October 16, 2008
    Report Date
    October 21, 2008
    Manufacturer
    ETHICON, INC.
    Product Code
    FTL
    PMA / PMN Number
    K974098
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DATE SENT TO THE FDA: 11/20/08. ABNORMAL VOIDING, CONCLUSION: NO CONCLUSION CAN BE DRAWN AT THIS TIME. SHOULD ADDITIONAL 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 GOODS RELEASE CRITERIA.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PT UNDERWENT A SLING PROCEDURE IN 2008. THE PT ALSO UNDERWENT A COLPORRHAPHY CONCOMITANTLY. DURING THE PROCEDURE, THE PT'S BLADDER WAS PERFORATED. AS A RESULT, THE DEVICE WAS REMOVED. UPON DISCHARGE, THE PT'S VOIDING PATTERN WAS ABNORMAL AND SHE HAD AN IN-DWELLING CATHETER IN PLACE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TENSION FREE VAGINAL TAPE MESH, SURGICAL, POLYMERIC FTL ETHICON, INC. NA 3128441

    Patients

    Seq Age Sex Outcome Treatment
    1 52 YR Required Intervention COLPORRHAPHY