BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CODMAN DISPOSABLE PERFORATOR

    MDR report key: 3841429 · Received May 30, 2014

    Report

    Report Number
    1226348-2014-11688
    Event Type
    Injury
    Date Received
    May 30, 2014
    Date of Event
    May 15, 2014
    Manufacturer
    CODMAN & SHURTLEFF
    Product Code
    HBF
    PMA / PMN Number
    PK791101
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

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

    Additional Manufacturer Narrative · 1

    THE PERFORATOR WAS NOT RETUNED FOR EVALUATION, AS SUCH IT IS NOT POSSIBLE TO EVALUATE THE PRODUCT AND DETERMINE THE ROOT CAUSE OF THIS COMPLAINT. THE DHR REVIEW FOR THE PERFORATOR (LOT CG025S) REVEALED THAT ALL TESTS AND INSPECTIONS ASSOCIATED WITH THE ASSEMBLY PROCESS MET SPECIFICATION REQUIREMENTS. WE WILL CONTINUE TO MONITOR FOR THIS OR SIMILAR COMPLAINTS FOR THIS PRODUCT CODE AND LOT NUMBER. TRENDS WILL BE MONITORED FOR THIS AND SIMILAR COMPLAINTS. AT THE PRESENT TIME THIS COMPLAINT IS CONSIDERED CLOSED. COMPLAINT SAMPLE NOT RETURNED.

    Description of Event or Problem · 1

    THE SALES REP CALLED TO REPORT THAT THE PERFORATOR FAILED TO STOP AND WENT THROUGH THE DURA. IT DID NOT PLUNGE. (B)(4) 2014 ADDITIONAL INFORMATION FROM THE REP STATED: EVENT AND ALERT DATE WERE BOTH YESTERDAY, (B)(6).

    Description of Event or Problem · 1

    ON 6/12/14 - THE CUSTOMER ADVISED THAT THE PRODUCT WAS DISCARDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    318240 CODMAN DISPOSABLE PERFORATOR DRILLS, BURRS, TREPHINES & ACC HBF CODMAN & SHURTLEFF CG025S

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention