BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DURDEN SUCTION INTEGRATED CAUTERY

    MDR report key: 69978 · Received February 13, 1997

    Report

    Report Number
    1042100-1997-00001
    Event Type
    Injury
    Date Received
    February 13, 1997
    Date of Event
    April 5, 1994
    Report Date
    February 3, 1997
    Manufacturer
    DURDEN ENTERPRISES, INC.
    Product Code
    GEI
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    ATTORNEY

    Narratives

    Description of Event or Problem · 1

    DESCRIPTION ON LAW SUIT: DURING A ROUTINE TONSILLECTOMY, PLAINTIFF SUFFERED A FLASH FIRE OF THE HYPOPHARYNX AND MOUTH.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 DURDEN SUCTION INTEGRATED CAUTERY ELECTRO SURGICAL GEI DURDEN ENTERPRISES, INC. UNK UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 NO INFO Hospitalization