BEUDAMED
    FDA Adverse Event Other Summary report: N

    NUPREP SKIN PREP GEL

    MDR report key: 19449268 · Received May 31, 2024

    Report

    Report Number
    MW5155690
    Event Type
    Other
    Date Received
    May 31, 2024
    Date of Event
    May 11, 2020
    Report Date
    May 31, 2024
    Manufacturer
    D. O. WEAVER AND COMPANY
    Product Code
    DRX
    Report Source
    Voluntary report
    Reporter Location
    DE, US
    Reporter Occupation
    OTHER
    Health Professional
    *

    Narratives

    Description of Event or Problem · 0

    NUPREP SKIN PREP GEL - NUPREP SKIN PREP GEL, 120G / 4OZ TUBES - WEAVER AND COMPANY 565 NUCLA WAY, UNIT B AURORA, CO 80011 USA. USED BY AN ENT DOCTOR EXAMINATION BY AN ENT SPECIALIST. PAINFUL SWELLING (FACE/LIPS). SEVERE PERSISTENT REDNESS, PAIN AND MASSIVE SWELLING AT THE ELECTRODE POSITIONS. ALTHOUGH THE PRODUCT WAS WIPED OFF/ WASHED OFF IMMEDIATELY, THE MASSIVE SIDE EFFECTS PERSISTED AND INTENSIFIED AFTER A WHILE. BURNING DUE TO APPLICATION OF NUPREP (DESPITE TREATMENT WITH FENISTIL GEL AND HOURS OF COOLING, SWELLING + BURNING FOR 2 DAYS). REACTION OCCURRED IMMEDIATELY AFTER A TEST WHERE PADS WERE APPLIED AND WAS SEVERE AFTER 20 MINUTES THE DOCTOR HAD TO BE CALLED ON THE ON-CALL PHONE IN THE EVENING TO INFORM HIM OF THE PERSISTENT SYMPTOMS. (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    173427 NUPREP SKIN PREP GEL ELECTRODE, ELECTROCARDIOGRAPH DRX D. O. WEAVER AND COMPANY

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown