BEUDAMED
    FDA Adverse Event Other Summary report: N

    DISPOSABLE CRANIAL PERFORATOR, DGR-0

    MDR report key: 562258 · Received May 18, 2004

    Report

    Report Number
    562258
    Event Type
    Other
    Date Received
    May 18, 2004
    Date of Event
    April 14, 2004
    Report Date
    May 18, 2004
    Manufacturer
    ACRA-CUT, INC.
    Product Code
    HTW
    Report Source
    User Facility report
    Reporter Location
    KY, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    DISPOSABLE CRANIAL PERFORATOR DID NOT DISENGAGE AND CAUSED A DURAL TEAR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 DISPOSABLE CRANIAL PERFORATOR, DGR-0 DRILL BIT HTW ACRA-CUT, INC. DGR-O 4905

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR