BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NEEDLE DRIVER

    MDR report key: 19564 · Received February 8, 1995

    Report

    Report Number
    MW1005072
    Event Type
    Malfunction
    Date Received
    February 8, 1995
    Date of Event
    February 2, 1995
    Report Date
    February 3, 1995
    Manufacturer
    MITEK SURGICAL PRODUCTS, INC.
    Product Code
    GDF
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    TN, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Description of Event or Problem · 1

    THE NEEDLE DRIVER BROKE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 NEEDLE DRIVER NEEDLE DRIVER GDF MITEK SURGICAL PRODUCTS, INC. GII

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR Other