BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CODMAN DISPOSABLE PERFORATOR

    MDR report key: 1970422 · Received January 17, 2011

    Report

    Report Number
    1226348-2011-00010
    Event Type
    Injury
    Date Received
    January 17, 2011
    Date of Event
    December 20, 2010
    Report Date
    December 20, 2010
    Manufacturer
    CODMAN & SHURTLEFF, INC.
    Product Code
    HBF
    PMA / PMN Number
    K791101
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    HISTORICALLY FOR COMPLAINTS OF THIS NATURE, THE RETURNED PERFORATORS HAVE BEEN VISUALLY INSPECTED AS RECEIVED, DISASSEMBLED AND CLEANED, AND THEN VISUALLY AND DIMENSIONALLY INSPECTED. NO DISCREPANCIES HAVE BEEN FOUND. THE PERFORATIONS HAVE BEEN REASSEMBLED AND WERE FUNCTIONALLY TESTED FOR CUTTING AND DRILLING. THEY'VE BEEN FOUND TO MEET SPECIFICATION REQUIREMENTS. THE REPORTED CONDITION COULD NOT BE DUPLICATED. REVIEWS OF THE DEVICE HISTORY RECORDS HAVE FOUND NO DISCREPANCIES. THE COMPLAINTS HAVE NOT BEEN CONFIRMED. A FOLLOW UP REPORT WILL BE FILED IF THE INVESTIGATION OF THIS DEVICE REVEALS A RESULT DIFFERENT FROM THAT WHICH IS STATED ABOVE OR IF ANY FURTHER INFO REGARDING THE CAUSE OR MODE OF FAILURE IS MADE AVAILABLE. OTHERWISE, THE COMPLAINT IS CONSIDERED TO BE CLOSED AT THIS TIME.

    Description of Event or Problem · 1

    CUSTOMER REPORTS THAT: "DISPOSABLE PERFORATOR FAILED TO DISENGAGE AND CAUSED DAMAGE TO THE DURA. PT IS OKAY".

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 50 YR Required Intervention