BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACRA CUT DISPOSABLE CRANIAL PERFORATOR 14MM DGRI

    MDR report key: 1820837 · Received August 26, 2010

    Report

    Report Number
    MW5017259
    Event Type
    Malfunction
    Date Received
    August 26, 2010
    Date of Event
    August 26, 2010
    Report Date
    August 26, 2010
    Manufacturer
    ACRA-CUT
    Product Code
    HBF
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    LA, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    STOP DEVICE DID NOT LIMIT DEPTH OF DRILL. PROCEDURE - RIGHT FRONTAL STEALTH CRANIOTOMY FOR RESECTION OF BRAIN MASS. DATE OF USE: (B)(6) 2010. EVENT ABATED AFTER USE: YES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ACRA CUT DISPOSABLE CRANIAL PERFORATOR 14MM DGRI ACRA CUT DISPOSABLE CRANIAL PERFORATOR 14MM HBF ACRA-CUT 200 241 CE 413 7590

    Patients

    Seq Age Sex Outcome Treatment
    1 55 YR