BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TENSION FREE VAGINAL TAPE

    MDR report key: 1031090 · Received April 16, 2008

    Report

    Report Number
    2210968-2008-00257
    Event Type
    Injury
    Date Received
    April 16, 2008
    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 2007. APPROXIMATELY TWO MONTHS AFTER THE PROCEDURE, A TWO CENTIMETER MESH EXPOSURE WAS NOTICED. THE MESH EXPOSURE WAS SITUATED NEAR THE VAGINAL INCISION THAT WAS MADE DURING THE INITIAL DEVICE IMPLANT PROCEDURE. SOON AFTER REALIZING THAT THERE WAS A MESH EROSION, THE SITE WAS CLEANED AND THE VAGINAL BREACH WAS RE-SUTURED. THE PT CONTINUED TO EXPERIENCE THE SAME PROBLEM AND THE MESH WAS REMOVED DURING 2008. AFTER REMOVING THE MESH, A PROPHYLACTIC ANTIBIOTIC TREATMENT AND ANTI-INFLAMMATORY MEDICINES WERE PRESCRIBED. 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 3020877

    Patients

    Seq Age Sex Outcome Treatment
    1 49 YR Required Intervention