BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CODMAN DISPOSABLE PERFORATOR

    MDR report key: 3143190 · Received May 28, 2013

    Report

    Report Number
    3143190
    Event Type
    Malfunction
    Date Received
    May 28, 2013
    Date of Event
    May 6, 2013
    Report Date
    May 24, 2013
    Manufacturer
    CODMAND AND SHURTLEFF, INC
    Product Code
    HBF
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    CA, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    A (B)(6) MALE IN SURGERY FOR CRANIOTOMY. "CRANIOTOME BURR DID NOT STOP AUTOMATICALLY" WHEN 1ST BURR HOLE DRILLED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    233340 CODMAN DISPOSABLE PERFORATOR NONE HBF CODMAND AND SHURTLEFF, INC KEO16 S

    Patients

    Seq Age Sex Outcome Treatment
    1