BEUDAMED
    FDA Adverse Event Other Summary report: N

    HYLATOPIC PLUS

    MDR report key: 4330452 · Received December 8, 2014

    Report

    Report Number
    MW5039563
    Event Type
    Other
    Date Received
    December 8, 2014
    Date of Event
    December 8, 2014
    Report Date
    December 8, 2014
    Manufacturer
    ONSET DERMATOLOGICS
    Product Code
    MGQ
    Adverse Event
    Yes
    Report Source
    Voluntary report
    Reporter Location
    GA, US
    Reporter Occupation
    PATIENT FAMILY MEMBER OR FRIEND

    Narratives

    Description of Event or Problem · 1

    MY HUSBAND PUT HYLATOPICPLUS CREAM ON OUR (B)(6) YEAR OLD. WHEN WE WOKE UP, HE HAD HIVES ON HIS LIMBS AND FACE. SEVERE ITCHY RASH ON LIMBS AND FACE. HE WAS GIVEN 1.5 TSP OF HYDROXYZINE. THE RASH WORSENED THROUGHOUT THE DAY. HIS ALLERGIST CALLED IN A PRESCRIPTION FOR A STEROID. DOSE OR AMOUNT: RUB ON SKIN, FREQUENCY: ONCE DAILY. DATES OF USE: (B)(6) 2014. EVENT ABATED AFTER USE STOPPED OR DOSE REDUCED? YES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    789171 HYLATOPIC PLUS HYLATOPIC PLUS MGQ ONSET DERMATOLOGICS * P2160614

    Patients

    Seq Age Sex Outcome Treatment
    1 5 YR Other