BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GYNEMESH PS

    MDR report key: 2873416 · Received December 12, 2012

    Report

    Report Number
    2873416
    Event Type
    Injury
    Date Received
    December 12, 2012
    Date of Event
    December 10, 2012
    Report Date
    December 12, 2012
    Manufacturer
    ETHICON, INC.
    Product Code
    FTL
    Adverse Event
    Yes
    Report Source
    User Facility report
    Reporter Location
    VA, US
    Reporter Occupation
    INVALID DATA

    Narratives

    Description of Event or Problem · 1

    PATIENT HAD TOTAL ABDOMINAL HYSTERECTOMY, ABDOMINAL SACROCOLPOPEXY, MIDURETHRAL SLING AND CYSTOSCOPY SURGERY 15 MONTHS AGO THAT WAS DONE FOR SYMPTOMATIC STAGE II UTEROVAGINAL PROLAPSE AND STRESS URINARY INCONTINENCE. PATIENT RECENTLY PRESENTS TO DOCTOR WITH DYSPAREUNIA AND 1 MONTH HISTORY OF VAGINAL DISCHARGE. PATIENT COMPLAINS OF ROUGH AREA ON VAGINAL WALL THAT IS PAINFUL DURING INTERCOURSE. PATIENT USING TOPICAL PREMARIN CREAM. PHYSICAL EXAM REVEALED TENDERNESS WITH A 1 CM VAGINAL APEX MESH EXPOSURE. PATIENT UNDERWENT SURGERY FOR REMOVAL OF EXPOSED MESH.THE ENTIRE EXTENT OF THE POSTERIOR VAGINAL WALL MESH WAS REMOVED. PATIENT WAS DISCHARGED FROM HOSPITAL WITH FOLLOWUP VISIT IN 12 DAYS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 GYNEMESH PS MESH, SURGICAL, VAGINAL FTL ETHICON, INC. GPSL DGE088

    Patients

    Seq Age Sex Outcome Treatment
    1 50 YR Hospitalization| R OTHER