BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ERBE USA INC.

    MDR report key: 381994 · Received March 11, 2002

    Report

    Report Number
    MW1024391
    Event Type
    Injury
    Date Received
    March 11, 2002
    Date of Event
    December 7, 2001
    Report Date
    March 11, 2002
    Manufacturer
    ERBE USA INC
    Product Code
    GEI
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    TX, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    PT COMPLAINED OF BURNING SENSATION WHILE ERBE ELECTRO SURGICAL UNIT IN USE. OPERATOR TURNED UNIT OFF AND SENT FOR INSPECTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ERBE USA INC. ELECTRO SURGICAL UNIT GEI ERBE USA INC ICC200 *

    Patients

    Seq Age Sex Outcome Treatment
    1 52 YR Required Intervention