BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DISPOSABLE CRANIAL PERFORATOR WITH HUDSON END 14/11MMR

    MDR report key: 4643383 · Received March 20, 2015

    Report

    Report Number
    MW5041677
    Event Type
    Injury
    Date Received
    March 20, 2015
    Date of Event
    February 7, 2015
    Report Date
    March 20, 2015
    Manufacturer
    ACRA-CUT INC,
    Product Code
    HBF
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    PERFORATOR DID NOT AUTO STOP WHEN IT REACHED SOFT TISSUE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    191799 DISPOSABLE CRANIAL PERFORATOR WITH HUDSON END 14/11MMR PERFORATOR HBF ACRA-CUT INC, 200-251 DGR-11 8692

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR