EASYDEX 100G FRUIT PUNCH DYE FREE
Received Nov 21, 2016 · Event occurred Sep 22, 2016
Report MW5066267 · MDR key 6124455
Device
Generic name
Easydex 100g Fruit Punch Dye Free
Manufacturer
Aeromed, Vineland Syrup Inc.Product problems
- Patient-Device Incompatibility
- Device Operates Differently Than Expected
Patient
39 YR
- Hypersensitivity/Allergic reaction
- Itching Sensation
- Rash
- Sleep Dysfunction
- Hypersensitivity/Allergic reaction
- Itching Sensation
- Rash
- Sleep Dysfunction
Narrative
Description of Event or Problem
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.