BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    A-CRAN BURR

    MDR report key: 1901195 · Received November 3, 2010

    Report

    Report Number
    1901195
    Event Type
    Malfunction
    Date Received
    November 3, 2010
    Date of Event
    August 4, 2010
    Report Date
    November 3, 2010
    Manufacturer
    THE ANSPACH EFFORT, INC.
    Product Code
    HBF
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    RI, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    PATIENT UNDERGOING RIGHT PARIETAL CRANIOTOMY FOR RESECTION OF MASS. WHILE TURNING THE FLAP, THE DRILL BIT BROKE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 A-CRAN BURR DRILL HBF THE ANSPACH EFFORT, INC. * *

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR