BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MENTOR

    MDR report key: 2223039 · Received August 21, 2011

    Report

    Report Number
    MW5021841
    Event Type
    Injury
    Date Received
    August 21, 2011
    Date of Event
    December 6, 2004
    Report Date
    August 21, 2011
    Manufacturer
    MENTOR
    Product Code
    GEI
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    NJ, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    MENTOR HELICAL TROCAR IMPLANTED FOR BLADDER SUSPENSION-MID URETHRAL SLING/OB TAPE. LATER NOTICED THAT IT HAD ERODED THROUGH CERVIX TISSUE. HAD TO BE REMOVED ON (B)(6) 2006. INCONTINENCE WORSE THAN BEFORE ORIGINAL SURGERY. HUMILIATION IN THAT THE PROBLEM REOCCURRED SO BADLY. HAD TO HAVE 3RD SURGERY-TVT RETROPUBIC TENSION-FREE VAGINAL TAPE URETHRAL SLING - DONE ON (B)(6) 2007. THREE SURGERIES RESULTED IN LOST TIME AT WORK AND A LOT OF SCAR TISSUE OBSCURING CERVIX AS WELL AS PAIN DURING RECOVERY. MULTIPLE TRIPS TO THE DR AND HOSP OVER A PERIOD OF 3 - 1/2 YEARS. SURGERIES - INCLUDING BUT NOT LIMITED TO ABOVE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MENTOR MENTOR HELICAL TROCAR GEI MENTOR

    Patients

    Seq Age Sex Outcome Treatment
    1 54 YR Life Threatening| O| R