BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SUCTION COAGULATOR

    MDR report key: 3955158 · Received July 18, 2014

    Report

    Report Number
    2242056-2014-00001
    Event Type
    Injury
    Date Received
    July 18, 2014
    Date of Event
    January 1, 2014
    Report Date
    July 18, 2014
    Manufacturer
    ALTO DEVELOPMENT CORP.
    Product Code
    GEI
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    IT IS NOT POSSIBLE TO DETERMINE THE ROOT CAUSE OF THE REPORTED EVENT WITHOUT AN EXAMINATION OF THE ACTUAL DEVICE USED IN THE PROCEDURE. ONE POSSIBLE CAUSE OF THE REPORTED EVENT MAY BE DAMAGED CANNULA INSULATION. AS THE 050-041 SUCTION COAGULATORS ARE PROVIDED NON-STERILE AND BULK PACKAGED, THEY ARE SUBJECT TO SHIPPING, HANDLING, 3RD PARTY PROCESSING, AND STERILIZATION BEYOND THE CONTROL OF ALTO DEVELOPMENT.

    Description of Event or Problem · 1

    THE COMPLAINT REPORTED THAT "THE SURGEON WAS PERFORMING A TONSILLECTOMY ON A (B)(6) YEAR OLD PATIENT USING THE A AND E 050-041NS ((B)(4)) 10FR SUCTION COAGULATOR. DURING THE PROCEDURE, THE SUCTION COAGULATOR BEGAN BURNING THE INSIDE OF THE PATIENT'S CHEEK AS WELL AS THE CORNER OF THE PATIENT'S MOUTH. THE BURNS ARE SEVERE AND MAY REQUIRE PLASTIC SURGERY TO REPAIR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    423313 SUCTION COAGULATOR SUCTION COAGULATOR GEI ALTO DEVELOPMENT CORP. 005

    Patients

    Seq Age Sex Outcome Treatment
    1 7 YR Other