BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACRA-CUT

    MDR report key: 333248 · Received May 15, 2001

    Report

    Report Number
    333248
    Event Type
    Injury
    Date Received
    May 15, 2001
    Date of Event
    May 10, 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 APPLYING MINIMAL PRESSURE DURING PROCEDURE, BIT FAILED TO DISENGAGE, CAUSING TEARING OF DURA, LEADING TO EMERGENT CRANIOTOMY TO CONTROL BLEEDING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    23084 ACRA-CUT CRANIAL PERFORATOR HBF ACRA-CUT, INC. DRG-1 3482

    Patients

    Seq Age Sex Outcome Treatment
    1 * Required Intervention