BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACRA CUT

    MDR report key: 2738881 · Received September 6, 2012

    Report

    Report Number
    MW5026816
    Event Type
    Injury
    Date Received
    September 6, 2012
    Date of Event
    August 16, 2012
    Report Date
    August 24, 2012
    Manufacturer
    ACRA CUT
    Product Code
    HBE
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    HI, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    TPS (STRYKER) PERFORMED WITH ACRACUT DRILL BIT (B)(64) WAS BEING USED FOR A RIGHT BURR HOLE WITH CT GUIDED BIOPSY. TPS DRILL BIT DID NOT STOP WHEN IT PASSED THROUGH THE SKULL. DRILL BIT PASSED THROUGH THE DURA. (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ACRA CUT CRANIAL PERFORATOR WITH DGR-I HUDSON END 14/11 MM-R HBE ACRA CUT 200-241-DGR-I 7685

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR Hospitalization