BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CODMAN DISP PERFORATOR

    MDR report key: 2050907 · Received April 4, 2011

    Report

    Report Number
    1226348-2011-00122
    Event Type
    Injury
    Date Received
    April 4, 2011
    Manufacturer
    CODMAN AND SHURTLEFF, INC.
    Product Code
    HBF
    PMA / PMN Number
    K791101
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    IT HAS BEEN COMMUNICATED THAT THE DEVICE AND/OR LOT INFORMATION IS NOT AVAILABLE FOR EVALUATION. WITHOUT THE DEVICE AND/OR LOT INFORMATION IT IS NOT POSSIBLE FOR CODMAN TO CONDUCT A PROPER INVESTIGATION. IF AT SOME POINT THE DEVICE AND/OR LOT INFORMATION DOES BECOME AVAILABLE, THIS COMPLAINT WILL BE RE-OPENED, EVALUATED AND A FOLLOW UP REPORT WILL BE FILED. TRENDS WILL BE MONITORED FOR THIS AND SIMILAR COMPLAINTS. AT THE PRESENT TIME THIS COMPLAINT IS CONSIDERED CLOSED.

    Description of Event or Problem · 1

    DURING THE SURGERY, PERFORATOR CAUSED DURA INJURY. ACCORDING TO THE SURGEON, THE DEVICE FUNCTIONED.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR Required Intervention