BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACRA

    MDR report key: 333256 · Received May 15, 2001

    Report

    Report Number
    333256
    Event Type
    Injury
    Date Received
    May 15, 2001
    Date of Event
    May 6, 2001
    Report Date
    May 14, 2001
    Manufacturer
    ACRA-CUT, INC
    Product Code
    HBF
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    SD, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    WHILE BURR HOLES WERE BEING DRILLED THE PERFORATION MAY HAVE MALFUNCTIONED. THE DURA WAS CONTACTED AND MAJOR BLEEDING OCCURRED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    22848 ACRA CRANIAL PERFORATOR HBF ACRA-CUT, INC 200-241-DGR-1 3482

    Patients

    Seq Age Sex Outcome Treatment
    1 51 YR Required Intervention