BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DISPOSABLE CRANIAL PERFORATOR

    MDR report key: 30793 · Received January 26, 1996

    Report

    Report Number
    30793
    Event Type
    Malfunction
    Date Received
    January 26, 1996
    Date of Event
    October 30, 1995
    Report Date
    November 15, 1995
    Manufacturer
    ACRA CUT
    Product Code
    HBF
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    PA, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    CRANIAL PERFORATOR DID NOT STOP SPINNING WHEN IT PASSED THROUGH THE BONE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 DISPOSABLE CRANIAL PERFORATOR DISPOSABLE CRANIAL PERFORATOR HBF ACRA CUT 200-271-D6R-O 1995

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR