BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TENSION FREE VAGINAL TAPE

    MDR report key: 726489 · Received June 16, 2006

    Report

    Report Number
    2210968-2006-00430
    Event Type
    Injury
    Date Received
    June 16, 2006
    Date of Event
    May 7, 2006
    Report Date
    May 18, 2006
    Manufacturer
    ETHICON, INC.
    Product Code
    FTL
    PMA / PMN Number
    k033568
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    EXPOSURE OF TVT TAPE CAN OCCUR FOR A VARIETY OF REASONS SUCH AS INADEQUAE MUCOSAL CLOSURE, ATROPHIC VAGINAL SKIN, OR POSTOPERAIVE TRAUMA TO NAME A FEW. THESE SOMETIMES CLOSE SPONTANEOUSLY WITH TIME AND ESTROGEN THERAPY BUT MOST REQUIRE RESECTION AND RECLOSUE. AS THIS EXPOSURE OCCURRED WITHIN ONE MONTH OF THE SURGERY, MOST LIKELY POSTOPERATIVE TRAUMA (I.E. INTERCOURSE). 510(K) # IS K033568

    Description of Event or Problem · 1

    THE PATIENT UNDERWENT A SLING PROCEDURE IN 2006 AND THE AREA WAS CLOSED WITH SUTURE. ALL WAS WELL AT THE INITIAL POSTOPERATIVE CHECK. AT FOUR WEEKS POSTOPERATIVE, THE PATIENT HAD INTERCOURSE AND THE HUSBAND FET THE MESH. THE PHYSICIAN REPORTS A 7MM PORTION OF MESH WAS EXPOSED SUBURETHRALLY.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR Required Intervention