BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ETHICON

    MDR report key: 1052208 · Received May 23, 2008

    Report

    Report Number
    MW5007036
    Event Type
    Injury
    Date Received
    May 23, 2008
    Date of Event
    July 30, 2007
    Report Date
    May 23, 2008
    Manufacturer
    JOHNSON & JOHNSON
    Product Code
    FTL
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    TX, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    I AM COMPLAINING ABOUT A MEDICAL DEVICE, THE PRO-LIFT SLING, UTILIZED WITH MY RECENT BLADDER SUSPENSION PROCEDURE PERFORMED IN 2007. I CONTINUED TO EXPERIENCE PAIN AND DISCOMFORT WITH A VAGINAL AREA WHICH DID HEAL APPROPRIATELY. ON APPROX FOUR AND A HALF MONTHS LATER, I HAD A SUBSEQUENT PROCEDURE AS AN OUTPATIENT TO REPAIR THE VAGINAL AREA. I CONTINUED TO HAVE PAIN AND SOUGHT A SECOND OPINION FROM A SECOND PHYSICIAN WHO VERBALLY TOLD ME THE PRO-LIFT SLING WAS LIKELY THE SOURCE OF MY PROBLEM. HE REFERRED ME TO ANOTHER SURGEON WHO IN 2008, SURGICALLY REMOVED THE PRO-LIFT SLING WHICH WAS EXTRUDING FROM THE REAR VAGINAL AREA. DATES OF USE: 7 1/2 HOURS, 2007 - 2008. DIAGNOSIS OR REASON FOR USE #1: URINARY FREQUENCY AT NIGHT. #2: URINE LEAKAGE WITH COUGH OR SNEEZE. EVENT ABATED AFTER USER STOPPED OR DOSE REDUCED?: YES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ETHICON GYNECARE PROLIFT FTL JOHNSON & JOHNSON UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 57 YR Hospitalization| O| S