BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN

    MDR report key: 2973482 · Received February 15, 2013

    Report

    Report Number
    2973482
    Event Type
    Injury
    Date Received
    February 15, 2013
    Date of Event
    February 8, 2013
    Report Date
    February 14, 2013
    Manufacturer
    UNKNOWN
    Product Code
    OTO
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    KY, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    VAGINAL MESH WAS SURGICALLY REMOVED DUE TO VAGINAL BLEEDING AND MESH EROSION OF THE VAGINAL WALL WITH SEVERE CYSTITIS. THE DATE AND LOCATION OF THE IMPLANT IS UNKNOWN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    69460 UNKNOWN VAGINAL MESH OTO UNKNOWN UNKNOWN UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 71 YR Hospitalization| R