BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PROLIFT PELVIC FLOOR REPAIR

    MDR report key: 728265 · Received June 22, 2006

    Report

    Report Number
    2210968-2006-00439
    Event Type
    Injury
    Date Received
    June 22, 2006
    Date of Event
    June 8, 2006
    Manufacturer
    ETHICON, INC.
    Product Code
    FTL
    PMA / PMN Number
    K013718
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    H6: CONCLUSION: EXPOSURE OF THE MESH 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; OTHERS REQUIRE RESECTION IN THE OFFICE OR THE OPERATING ROOM. EXPOSURE IS A RISK WITH USE OF ANY FOREIGN MATERIAL. (510(K)#K013718)

    Description of Event or Problem · 1

    THE PATIENT UNDERWENT A PELVIC FLOOR REPAIR PROCEDURE IN 2006. POSTOPERATIVELY, THE PATIENT EXPERIENCED VAGINAL MESH EXPOSURE, WHICH WAS NOTED DURING A FOLLOW UP VISIT WITH THE PHYSICIAN SIX WEEKS LATER. A PARTIAL EXCISION OF THE MESH WAS PERFORMED ABOUT THREE MONTHS LATER AND PREMARIN CREAM WAS APPLIED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PROLIFT PELVIC FLOOR REPAIR MESH, SURGICAL , POLYMERIC FTL ETHICON, INC. NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 54 YR Hospitalization