BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CODMAN

    MDR report key: 550268 · Received July 26, 2004

    Report

    Report Number
    MW1032809
    Event Type
    Injury
    Date Received
    July 26, 2004
    Date of Event
    June 1, 2004
    Report Date
    June 19, 2004
    Manufacturer
    CODMAN & SHURTLEFF INC. A J & J CO.
    Product Code
    HBF
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    TX, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Description of Event or Problem · 1

    DR WAS MAKING A BURR HOLE IN THE BONE TO PLACE A BURR HOLE VALVE FOR A V-P SHUNT. THE STOP DID NOT ENGAGE, THE BURR CONTINUED THE ROTATE, TEARING THE DURA.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CODMAN DISPOSABLE PERFORATOR 14MM HBF CODMAN & SHURTLEFF INC. A J & J CO. * DW892

    Patients

    Seq Age Sex Outcome Treatment
    1 54 YR Required Intervention