BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CODMAN DISPOSABLE PERFORATOR

    MDR report key: 1032337 · Received April 22, 2008

    Report

    Report Number
    1226348-2008-00099
    Event Type
    Injury
    Date Received
    April 22, 2008
    Date of Event
    March 21, 2008
    Report Date
    March 24, 2008
    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

    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 PERFORATORS 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

    AFFILIATE REPORTED, A DISENGAGEMENT FAILURE. DURING THE OPERATION, THE PERFORATOR DID NOT STOP AND IT CAUSED DURA INJURY TO THE PT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CODMAN DISPOSABLE PERFORATOR DRILLS, BURRS, TREPHINES & ACC HBF CODMAN & SHURTLEFF, INC. NA KZ935

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK