BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ELECTROSURGICAL UNIT

    MDR report key: 31094 · Received December 18, 1995

    Report

    Report Number
    31094
    Event Type
    Injury
    Date Received
    December 18, 1995
    Date of Event
    November 11, 1995
    Report Date
    December 15, 1995
    Manufacturer
    BIRTCHER MEDICAL SYSTEMS, INC.
    Product Code
    GEI
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    NJ, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    PAD ON PT DID NOT STICK WELL AND A BURN (SIZE OF A QUARTER) NOTED ON RIGHT THIGH. ALSO AREA WHERE PAD STUCK WAS RED. BURN THIRD DEGREE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ELECTROSURGICAL UNIT ELECTROSURGICAL UNIT GEI BIRTCHER MEDICAL SYSTEMS, INC. 5000

    Patients

    Seq Age Sex Outcome Treatment
    1 90 YR Hospitalization| R