BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CODMAN DISPOSABLE PERFORATOR

    MDR report key: 3162845 · Received June 11, 2013

    Report

    Report Number
    1226348-2013-18518
    Event Type
    Injury
    Date Received
    June 11, 2013
    Date of Event
    May 14, 2013
    Manufacturer
    CODMAN & SHURTLEFF, INC.
    Product Code
    HBF
    PMA / PMN Number
    PK791101
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    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 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 INFORMATION 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

    THE AFFILIATE REPORTED THAT THE PERFORATOR DID NOT STOP, PERFORATING THE DURA.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    261807 CODMAN DISPOSABLE PERFORATOR DRILLS, BURRS, TREPHINES & ACC. HBF CODMAN & SHURTLEFF, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention