BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GYNECARE PROLIFT

    MDR report key: 1210944 · Received October 23, 2008

    Report

    Report Number
    MW5008748
    Event Type
    Injury
    Date Received
    October 23, 2008
    Date of Event
    May 30, 2007
    Report Date
    October 23, 2008
    Manufacturer
    GYNECARE
    Product Code
    FTL
    Adverse Event
    Yes
    Report Source
    Voluntary report
    Reporter Location
    CT, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    PAIN, DISCOMFORT, VAGINAL EROSION AND URETHRAL PROBLEMS ASSOCIATED WITH MESH IMPLANTS. DATES OF USE: PLACED IN 2007. DIAGNOSIS OR REASON FOR USE: PROLAPSE OF PELVIC ORGANS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 GYNECARE PROLIFT MESH IMPLANT MATERIAL FTL GYNECARE

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention| S MONARC TRANSOBDURATOR SLING