BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INNOMED, INC.

    MDR report key: 1772080 · Received July 21, 2010

    Report

    Report Number
    MW5016825
    Event Type
    Malfunction
    Date Received
    July 21, 2010
    Date of Event
    July 19, 2010
    Report Date
    July 21, 2010
    Manufacturer
    INNOMED, INC.
    Product Code
    HWK
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    GA, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    TREPHINE BROKEN WHILE PHYSICIAN WAS USING IT, NO INJURY TO PT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INNOMED, INC. 4.7 MM TREPHINE HWK INNOMED, INC. 06095

    Patients

    Seq Age Sex Outcome Treatment
    1 36 YR