BEUDAMED
    FDA Adverse Event Other Summary report: N

    DISPOSABLE CRANIAL PERFORATOR

    MDR report key: 5137236 · Received May 21, 2004

    Report

    Report Number
    5137236
    Event Type
    Other
    Date Received
    May 21, 2004
    Date of Event
    April 14, 2004
    Report Date
    May 18, 2004
    Manufacturer
    ACRA-CUT INC.
    Product Code
    HBF
    Report Source
    User Facility report
    Reporter Location
    KY, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    EVENT DESCRIPTION: DISPOSABLE CRANIAL PERFORATOR DID NOT DISENGAGE. DURAL TEAR.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR Other