BEUDAMED
    FDA Adverse Event Other Summary report: N

    ACRA-CUT

    MDR report key: 617157 · Received June 10, 2005

    Report

    Report Number
    617157
    Event Type
    Other
    Date Received
    June 10, 2005
    Date of Event
    May 26, 2005
    Report Date
    June 10, 2005
    Manufacturer
    ACRA-CUT INC.
    Product Code
    HBF
    Report Source
    User Facility report
    Reporter Location
    MI, US

    Narratives

    Description of Event or Problem · 1

    A 14 MM. ACRACUT PERFORATOR FAILED TO STOP DURING PERFORATION OF SKULL AFTER PASSING THROUGH BONE MATTER. THE PERFORATOR WENT THROUGH THE DURA LAYER AND BRUISED A SMALL AREA OF BRAIN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ACRA-CUT SKULL PERFORATOR HBF ACRA-CUT INC. 5394 *

    Patients

    Seq Age Sex Outcome Treatment
    1 74 YR