BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CODMAN* DISP PERFORATOR

    MDR report key: 2882383 · Received December 20, 2012

    Report

    Report Number
    1226348-2012-84038
    Event Type
    Malfunction
    Date Received
    December 20, 2012
    Date of Event
    November 29, 2012
    Manufacturer
    CODMAN & SHURTLEFF, INC
    Product Code
    HBF
    PMA / PMN Number
    PK791101
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    IT IS NOT CLEAR AT THIS POINT IF THE DEVICE AND/OR LOT INFORMATION IS AVAILABLE. WITHOUT THE DEVICE AND/OR LOT INFORMATION IT IS NOT POSSIBLE FOR CODMAN TO CONDUCT A PROPER INVESTIGATION. IF THE DEVICE IS RETURNED, THE COMPLAINT WILL BE INVESTIGATED AND A FOLLOW UP REPORT WILL BE FILED. IF LOT INFORMATION DOES BECOMES AVAILABLE AND IF THE RECORD REVIEW INDICATES THAT THERE WAS A NON-CONFORMITY A FOLLOW UP REPORT WILL BE FILED. TRENDS WILL BE MONITORED FOR THIS AND SIMILAR COMPLAINTS. AT THE PRESENT TIME THIS COMPLAINT IS CLOSED. DEVICE EVALUATED BY MFR: UNCLEAR IF DEVICE IS AVAILABLE.

    Description of Event or Problem · 1

    REP REPORTED THAT THE PERFORATOR EITHER PLUNGED AND/ OR THE END CAME OUT OF THE DRIVER DURING USE. NO REPORT OF INJURY WAS COMMUNICATED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CODMAN* DISP PERFORATOR DRILLS, BURRS, TREPHINES & ACC HBF CODMAN & SHURTLEFF, INC

    Patients

    Seq Age Sex Outcome Treatment
    1