BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CODMAN TRIGEMINAL FCP DWN

    MDR report key: 2523597 · Received April 9, 2012

    Report

    Report Number
    1226348-2012-00191
    Event Type
    Injury
    Date Received
    April 9, 2012
    Manufacturer
    CODMAN AND SHURTLEFF - RAYNHAM
    Product Code
    GEN
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, 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. DEVICE NOT AVAILABLE.

    Description of Event or Problem · 1

    REP EXPLAINED THAT THE SURGEON WAS USING NON INSULATED FORCEPS WORKING THRU THE PATIENTS MOUTH. THE MOUTH WAS BEING HELD OPEN BY A RETRACTOR. THE LIKELY CAUSE OF THE INCIDENT OCCURRED WHEN THE SURGEONS NON INSULATED FORCEPS TOUCHED THE METAL RETRACTOR, CAUSING THE BIPOLAR CIRCUIT TO SHORT CIRCUIT AND A BURN TO THE PATIENTS LIP.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CODMAN TRIGEMINAL FCP DWN FORCEPS, GENERAL PLASTIC SURGERY GEN CODMAN AND SHURTLEFF - RAYNHAM

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention