BEUDAMED
    FDA Adverse Event Other Summary report: N

    NUPREP GEL

    MDR report key: 377019 · Received February 6, 2002

    Report

    Report Number
    1718791-2002-00001
    Event Type
    Other
    Date Received
    February 6, 2002
    Date of Event
    December 1, 2001
    Report Date
    February 6, 2002
    Manufacturer
    WEAVER & CO.
    Product Code
    GYB
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    THREE PTS HAD SCABBING LESIONS AT SITE OF ELECTRODES DUE TO THE SKIN PREP OR THE PASTE AND ELECTRODE. APPROX 10 MM IN DIAMETER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 NUPREP GEL SKIN PREP GEL (ABRASIVE) GYB WEAVER & CO. 10-30 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Other TEN20 CONDUCTIVE GEL.