BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GYNECARE PROLIFT - TOTAL PELVIC FLOOR REPAIR

    MDR report key: 1220905 · Received October 31, 2008

    Report

    Report Number
    MW5008866
    Event Type
    Injury
    Date Received
    October 31, 2008
    Date of Event
    October 28, 2008
    Report Date
    October 31, 2008
    Manufacturer
    ETHICON WOMENS HEATH
    Product Code
    FTL
    Adverse Event
    Yes
    Report Source
    Voluntary report
    Reporter Location
    PA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    PATIENT UNDERWENT A TOTAL PROLIFT PROCEDURE -VAGINAL MESH KIT- IN 2007, FOR STAGE 2 PELVIC ORGAN PROLAPSE. SHE HAS DONE WELL WITH RESOLUTION OF PROLAPSE AND IS VERY HAPPY WITH PROCEDURE, BUT WAS NOTED TO HAVE A SMALL MESH EXPOSURE ANTERIORLY AT 6 MONTHS. THIS HAS BEEN ASSOCIATED WITH A MINIMAL DISCHARGE AND BLEEDING. WE EXCISED THE EXPOSED MESH SIX MONTHS LATER, EASILY, AS AN OUTPATIENT. DATES OF USE: 2007 -- 2008. DIAGNOSIS OR REASON FOR USE: PELVIC ORGAN PROLAPSE. EVENT ABATED AFTER USE STOPPED OR DOSE REDUCED? YES. EVENT REAPPEARED AFTER REINTRODUCTION? NO.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 GYNECARE PROLIFT - TOTAL PELVIC FLOOR REPAIR TOTAL PROLIFT FTL ETHICON WOMENS HEATH PFRTO1

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR Disability