BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GYNECARE TOTAL PROLIFT

    MDR report key: 5213178 · Received November 10, 2015

    Report

    Report Number
    5213178
    Event Type
    Malfunction
    Date Received
    November 10, 2015
    Date of Event
    September 3, 2014
    Report Date
    November 6, 2015
    Manufacturer
    ETHICON, INC.
    Product Code
    OTN
    Adverse Event
    Yes
    Report Source
    User Facility report
    Reporter Location
    MI, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    PREOPERATIVE DIAGNOSIS: VAGINAL MESH EROSION, DYSPAREUNIA. POSTOPERATIVE DIAGNOSIS: SAME. PROCEDURE: TRANSVAGINAL MESH REMOVAL, POSTERIOR COLPORRHAPHY, CYSTOSCOPY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    746275 GYNECARE TOTAL PROLIFT MESH, SURGICAL, GYNECOLOGIC, FOR STRESS URINARY INCONTINENCE, FEMALE OTN ETHICON, INC. UNKNOWN UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 0 YR Other