BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CODMAN & SHURTLEFF, INC.

    MDR report key: 3647333 · Received February 26, 2014

    Report

    Report Number
    1226348-2014-11263
    Event Type
    Malfunction
    Date Received
    February 26, 2014
    Date of Event
    February 2, 2014
    Manufacturer
    CODMAN & SHURTLEFF, INC.
    Product Code
    HBF
    PMA / PMN Number
    PK791101
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    UPON COMPLETION OF THE INVESTIGATION, IT WAS NOTED THAT THE SUPPLIER EVALUATED THIS COMPLAINT. THE SUPPLIER DETERMINED THAT THAT THE ROOT CAUSE OF THE COMPLAINT COULD NOT BE VERIFIED. THE RETURNED PERFORATORS EXHIBITED OBVIOUS CUSTOMER MISUSE. NO CORRECTIVE ACTIONS TAKEN. TRENDS WILL BE MONITORED FOR THIS AND SIMILAR COMPLAINTS. AT THE PRESENT TIME THIS COMPLAINT IS CONSIDERED CLOSED.

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    THE AFFILIATE REPORTED "PERFORATOR NOT WORKING PROPERLY". ON (B)(6) 2014 AFFILIATE WAS CONTACTED REGARDING PRODUCT QUANTITY - 11. DOES THIS COMPLAINT INVOLVE 11 PATIENTS? ALSO DID PATIENT INJURY OCCUR AND WAS SURGERY DELAYED FOR GREATER THAN 30 MINUTES? AND TO ADD FURTHER EXPLANATION FOR "PERFORATOR NOT WORKING PROPERLY". ON (B)(6) THE PERFORATOR NOT WORKING PROPERLY MEANT THE PERFORATOR WAS DULL NOT AS SHARP AS THE EARLIER CODMAN PERFORATORS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    118109 CODMAN & SHURTLEFF, INC. DRILLS, BURRS, TREPHINES & ACC. HBF CODMAN & SHURTLEFF, INC. AE024S

    Patients

    Seq Age Sex Outcome Treatment
    1