BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FREER SEPTUM ELEVATOR

    MDR report key: 2523931 · Received April 9, 2012

    Report

    Report Number
    1226348-2012-00192
    Event Type
    Injury
    Date Received
    April 9, 2012
    Date of Event
    February 14, 2012
    Report Date
    March 13, 2012
    Manufacturer
    CODMAN AND SHURTLEFF - RAYNHAM
    Product Code
    GEG
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    RI, US
    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

    MEDWATCH REPORT EXPLAINED THAT ORTHOPEDIC INSTRUMENT, CODMAN 28 STAINLESS BROKE DURING USE. ADDITIONAL INFORMATION EXPLAINED; THE PIECE WAS RETRIEVED WITHOUT ANY ADVERSE CONSEQUENCES. XRAY WAS TAKEN TO ENSURE PIECE WAS FULLY REMOVED. NO ADDITIONAL STEPS WERE TAKEN. NO DELAY GREATER THAN 30 MINUTES. DEVICE IS AVAILABLE FOR EVAL. LOT NUMBER NOT AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 FREER SEPTUM ELEVATOR ELEVATOR, SURGICAL, GENERAL, PLASTIC SURGERY GEG CODMAN AND SHURTLEFF - RAYNHAM

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention