BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNK

    MDR report key: 2892193 · Received December 28, 2012

    Report

    Report Number
    2892193
    Event Type
    Malfunction
    Date Received
    December 28, 2012
    Date of Event
    December 11, 2012
    Report Date
    December 28, 2012
    Manufacturer
    UNK
    Product Code
    OTO
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    SC, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    PATIENT HAD DEVICE IMPLANTED AT A FACILITY IN ANOTHER STATE ON AN UNKNOWN DATE. UROLOGIST REMOVED SLING THAT HAD ERODED VAGINAL MUCOSA.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 UNK MESH, GYNECOLOGIC OTO UNK UNK UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR NONE KNOWN