BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CODMAN DISPOSABLE PERFORATOR 14 MM

    MDR report key: 2994128 · Received February 12, 2013

    Report

    Report Number
    2994128
    Event Type
    Malfunction
    Date Received
    February 12, 2013
    Date of Event
    September 22, 2012
    Report Date
    December 19, 2012
    Manufacturer
    CODMAN, A JOHNSON & JOHNSON COMPANY
    Product Code
    HBE
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    MD, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    PATIENT WAS UNDERGOING A CRANIOTOMY. THE DRILL PERFORATOR BROKE IN HALF AND THE INSTRUMENT WAS STUCK IN THE PATIENT'S HEAD FOR 30 MINUTES AND REMOVED WITHOUT INCIDENT. NO HARM TO PATIENT.WHAT WAS THE ORIGINAL INTENDED PROCEDURE?CRANIOTOMY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    62151 CODMAN DISPOSABLE PERFORATOR 14 MM DRILLS, BURRS, TREPHINES & ACCESSORIES (SIMPLE, POWERED) HBE CODMAN, A JOHNSON & JOHNSON COMPANY * 3210994

    Patients

    Seq Age Sex Outcome Treatment
    1 88 YR
    2 *