BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DISPOSABLE CRANIAL PERFORATOR WITH HUDSON END, 14 MM R

    MDR report key: 19994 · Received February 27, 1995

    Report

    Report Number
    MW1005242
    Event Type
    Injury
    Date Received
    February 27, 1995
    Date of Event
    February 15, 1995
    Report Date
    February 22, 1995
    Manufacturer
    ACRA-CUT, INC.
    Product Code
    HBF
    Adverse Event
    Yes
    Report Source
    Voluntary report
    Reporter Location
    CO, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    NEUROSURGEON FEELS THE SPRING ACTION ON DRILL BIT MAY HAVE MALFUNCTIONED, CAUSING BONE FRAGMENT TO BE PUSHED INTO BRAIN, CAUSING SEVERE BLEEDING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 DISPOSABLE CRANIAL PERFORATOR WITH HUDSON END, 14 MM R DISPOSABLE CRANIAL PERFORATOR HBF ACRA-CUT, INC. 1937

    Patients

    Seq Age Sex Outcome Treatment
    1 77 YR Hospitalization| L| R