BEUDAMED
    FDA Adverse Event Other Summary report: N

    *

    MDR report key: 171307 · Received June 3, 1998

    Report

    Report Number
    171307
    Event Type
    Other
    Date Received
    June 3, 1998
    Date of Event
    May 27, 1998
    Report Date
    June 2, 1998
    Manufacturer
    DAVOL INC.
    Product Code
    GEI
    Adverse Event
    Yes
    Report Source
    User Facility report
    Reporter Location
    MI, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    WHEN TAKING BOVIE PAD OFF PT, AN AREA OF WHITE TISSUE WAS DISCOVERED ON THE LEFT THIGH. PT TREATED FOR BURN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 * ELECTRICAL-SURGICAL UNIT GEI DAVOL INC. 5000 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 59 YR Other DATEX MONITORING SYSTEM (ANESTHESIA EQUIPMENT).