BEUDAMED
    FDA Adverse Event Other Summary report: N

    REM POLYHESIVE II

    MDR report key: 14439 · Received June 30, 1994

    Report

    Report Number
    MW1002679
    Event Type
    Other
    Date Received
    June 30, 1994
    Date of Event
    June 13, 1994
    Report Date
    June 21, 1994
    Manufacturer
    VALLEYLAB, INC.
    Product Code
    GEI
    Report Source
    Voluntary report
    Reporter Location
    AZ, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    REDDENED AREA AT BOVIE SITE ON RIGHT THIGH, ALSO RIGHT LATERAL GLUTEAL AREA; TWO SITES APPROX 3 X 4 AND 4 X 4. THEY ARE REDDENED AND SLIGHTLY RAISED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 REM POLYHESIVE II BOVIE PAD GEI VALLEYLAB, INC. H192E75071I

    Patients

    Seq Age Sex Outcome Treatment
    1 39 YR Other