BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CODMAN DISPOSABLE PERFORATOR

    MDR report key: 1924889 · Received December 9, 2010

    Report

    Report Number
    1226348-2010-00426
    Event Type
    Injury
    Date Received
    December 9, 2010
    Date of Event
    October 28, 2010
    Manufacturer
    CODMAN & SHURTLEFF, INC.
    Product Code
    HBF
    PMA / PMN Number
    K791101
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    UPON COMPLETION OF THE INVESTIGATION A FOLLOW UP REPORT WILL BE FILED.

    Description of Event or Problem · 1

    MHRA REPORTED THAT THE CUTTER IS DESIGNED TO STOP WHEN THEY PERFORATE THE SKULL BONE, THIS FAILED AND CONTINUED CUTTING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CODMAN DISPOSABLE PERFORATOR DRILLS, BURRS, TREPHINES & ACC. HBF CODMAN & SHURTLEFF, INC. NA HC009S

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Required Intervention