BEUDAMED
    FDA Adverse Event Injury Summary report: N

    132030-EMS GENERATOR SYSTEM 5000

    MDR report key: 447421 · Received March 6, 2003

    Report

    Report Number
    1213643-2003-00011
    Event Type
    Injury
    Date Received
    March 6, 2003
    Date of Event
    January 4, 2002
    Report Date
    February 18, 2003
    Manufacturer
    DAVOL, INC. (RI)
    Product Code
    GEI
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    ATTORNEY

    Narratives

    Description of Event or Problem · 1

    PATIENT BURN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 132030-EMS GENERATOR SYSTEM 5000 350101801-MONOPOLAR FOOTSWITCH GEI DAVOL, INC. (RI) * UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 * Required Intervention