BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TENSION FREE VAGINAL TAPE

    MDR report key: 1031086 · Received April 16, 2008

    Report

    Report Number
    2210968-2008-00256
    Event Type
    Injury
    Date Received
    April 16, 2008
    Date of Event
    December 1, 2007
    Report Date
    March 17, 2008
    Manufacturer
    ETHICON, INC.
    Product Code
    FTL
    PMA / PMN Number
    K974098
    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: 04/16/2008. 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 GOOD RELEASE CRITERIA.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PT UNDERWENT A SLING PROCEDURE IN 2006. IN 2007, A TWO CENTIMETER MESH EXPOSURE WAS NOTICED. THE EXPOSED MESH WAS SITUATED NEAR THE VAGINAL INCISION THAT WAS MADE DURING THE INITIAL DEVICE IMPLANT PROCEDURE. DURING 2007, A PROCEDURE WAS PERFORMED IN THE PHYSICIAN'S OFFICE TO REMOVE THE MESH IN THE SUB-URETHRAL AREA. THE PT HAS NOW RECOVERED AND IS CONTINENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TENSION FREE VAGINAL TAPE MESH, SURGICAL, POLYMERIC FTL ETHICON, INC. NA 2911750

    Patients

    Seq Age Sex Outcome Treatment
    1 39 YR Required Intervention