BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACRA-CUT

    MDR report key: 1746137 · Received June 30, 2010

    Report

    Report Number
    1746137
    Event Type
    Malfunction
    Date Received
    June 30, 2010
    Date of Event
    June 21, 2010
    Report Date
    June 29, 2010
    Manufacturer
    ACRA-CUT INC.
    Product Code
    HBF
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    PA, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    DISPOSABLE CRANIAL PERFORATOR W/HUDSON END 14/11 MMR # 200-271 DGR-O LOT # 7585. AUTOMATIC "STOP" MECHANISM DO NOT ENGAGE DURING DRILLING OF BURR HOLE. DRILL WENT THROUGH THE DURA AND MADE CONTACT WITH THE BRAIN. "BRAIN BRUISE" NOTED BY SURGEON.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ACRA-CUT CRANIAL PERFORATOR HBF ACRA-CUT INC. 200-271 DGR-O 7585

    Patients

    Seq Age Sex Outcome Treatment
    1 71 YR