BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TENSION FREE VAGINAL TAPE

    MDR report key: 726504 · Received June 16, 2006

    Report

    Report Number
    2210968-2006-00426
    Event Type
    Injury
    Date Received
    June 16, 2006
    Report Date
    May 18, 2006
    Manufacturer
    ETHICON, INC.
    Product Code
    FTL
    PMA / PMN Number
    k974098
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    EXPOSURE OF TVT TAPE CAN OCCUR FOR A VARIETY OF REASONS SUCH AS INADEQUATE MUCOSAL CLOSURE, ATROPHIC VAGINAL SKIN, OR POSTOPERATIVE TRAUMA TO NAME A FEW. THESE SOMETIMES CLOSE SPONTANEOUSLY WITH TIME AND ESTROGEN THERAPY BUT MOST REQUIRE RESECTION AND RECLOSURE. AS IT IS KNOWN THAT NO MESH WAS EXPOSED AT TWO YEARS POSTOP, THIS APPEARS TO BE A CASE OF TRUE LATE TERM EROSION THAT REQUIRED INTERVENTION TO PREVENT LONG TERM IMPAIRMENT. 510(K)# IS K974098

    Description of Event or Problem · 1

    THE PATIENT UNDERWENT A SLING PROCEDURE DURING 2002. FOUR YEARS POSTOPERATIVELY THE PATIENT DEVELOPED A BLADDER STONE ASSOCIATED WITH EXPOSURE OF THE MESH AT THE BLADDER NECK. THE PATIENT HAD UNDERGONE CYSTOSCOPY TWO YEARS AFTER THE PROCEDURE FOR A COLLAGEN INJECTION AND NO TAPE WAS NOTED IN THE URETHRA OR BLADDER AT THAT TIME. CYSTOSCOPY WITH STONE REMOVAL AND HOLMINUM LASER OF THE TAPE WAS PERFORMED.

    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 UNKNOWN Required Intervention