BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EASYDEX 100G FRUIT PUNCH DYE FREE

    MDR report key: 6124455 · Received November 21, 2016

    Report

    Report Number
    MW5066267
    Event Type
    Injury
    Date Received
    November 21, 2016
    Date of Event
    September 22, 2016
    Report Date
    September 28, 2016
    Manufacturer
    AEROMED, VINELAND SYRUP INC.
    Product Code
    MRV
    Adverse Event
    Yes
    Report Source
    Voluntary report
    Reporter Location
    US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    EXTREME HIVES (B)(6) PREGNANT. DRANK AEROMED EASYDEX 100G BVO AND DYE FREE FRUIT PUNCH FOR 3 HOURS GLUCOSE GESTATIONAL DIABETES SCREEN. BROKE OUT IN EXTREMELY ITCHY, HUGE HIVES ACROSS BELLY, UNDER ARMS, SIDE BODY, BACK, GROIN, FEET. OVER A WEEK WITH THEM STILL, NO SLEEP FOR 5 DAYS DUE TO ITCHING, AND NOW (B)(6) PREGNANT. DID 1 HOUR SCREEN (B)(6) 2016 AND IN RETROSPECT HAD A FEW TINY RED DOTS ON BELLY AFTER, HOWEVER DIDN'T THINK ANYTHING OF IT. NOW, IT'S CLEAR I HAD A SEVERE REACTION TO THE HIGHER DOSAGE. I WANT CLARIFICATION ON SAFETY STUDIES AS SOME NOTE EXTREME SKIN ISSUES ANIMAL TRIALS (I.E. SODIUM HEXAMETAPHOSPHATE), I WANT CLARIFICATION WHAT PERCENTAGE EACH INGREDIENT, ETC, SO HOPING NO HARM TO MY BABY AND THAT MY REACTION CLEARS. HOW WAS IT TAKEN OR USED: ORAL. DATE THE PERSON FIRST STARTED TAKING OR USING THE PRODUCT: (B)(6) 2016. DATE THE PERSON STOPPED TAKING OR USING THE PRODUCT: (B)(6) 2016. DID THE PERSON STOP AFTER THE PERSON REDUCED THE DOSE OR STOPPED TAKING OR USING THE PRODUCT: NO. DID THE PROBLEM RETURN IF THE PERSON STARTED TAKING OR USING THE PRODUCT AGAIN: YES. PREGNANT SCREEN GESTATIONAL DIABETES 1 HR AND 3 HR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    770180 EASYDEX 100G FRUIT PUNCH DYE FREE EASYDEX 100G FRUIT PUNCH DYE FREE MRV AEROMED, VINELAND SYRUP INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 39 YR Other