THERMAL ON DRY EYE COMPRESS
Received Jan 19, 2021 · Event occurred Jan 4, 2021
Report MW5098877 · MDR key 11200906
Device
Product problems
- Labelling, Instructions for Use or Training Problem
Patient
48 YR
- Hypersensitivity/Allergic reaction
- Itching Sensation
- Rash
- Swelling
- Hypersensitivity/Allergic reaction
- Itching Sensation
- Rash
- Swelling
Narrative
Description of Event or Problem
MY EYE DOCTOR DIAGNOSED ME AS HAVING CHRONIC DRY EYE DUE TO CLOGGED TEAR DUCKS. RECOMMENDED I USE THIS PRODUCT WHICH I BOUGHT FROM THE EYE DOCTOR OFFICE. THERMAL ON MOIST HEAT COMPRESS. I AM SEVERELY ALLERGIC TO SHELLFISH AND HAVEN'T COME INTO CONTACT WITH OTHER PRODUCTS AS WELL NOT LABELED AS CONTAINING SHELLFISH. I USED THE THERMAL DRYING I MOIST HEAT COMPRESS FOR 10 MINUTES BEFORE BEDTIME AS RECOMMENDED. THE NEXT MORNING, I HAD A RASH AROUND MY MOUTH AND CHEEKS. THOUGHT MAYBE IT WAS SOMETHING I ATE. SO, I USE THE MASK AGAIN. WOKE UP THE NEXT MORNING RASH A LITTLE MORE SEVERE AND EYES ARE A LITTLE SWOLLEN. STILL NOT WANTING TO BELIEVE IT WAS THE MASK, THOUGHT IT THAT WOULD BE IMPOSSIBLE. I USED IT AGAIN. THIRD DAY OF USING I WOKE UP WITH EYES SWELLED SHUT, LIPS SWELLED AND CRACKING AND A HEAVIER RASH ALL OVER HER FACE. EYES AND FACE VERY ITCHY. THIS HAS ALSO HAPPENED USING (B)(6) BRAND EYELINER THAT CONTAIN GROUND UP OYSTERS. I FOUND OUT LATER THAT SINCE OYSTERS ARE NOT A MAN-MADE PRODUCT THEY DO NOT NEED TO BE LISTED AS INGREDIENTS. I'M CURRENTLY LOOKING FOR SOME TYPE OF RELIEF FOR MY DRY EYES. BUT VERY SCARED TO USE ANYTHING BECAUSE SHELLFISH CONTAINING PRODUCTS ARE NOT LISTED ON INGREDIENT LABELS AND THEY SHOULD BE. I'VE SPENT SEVERAL DAYS GOING TO URGENT CARE, HAD TO TAKE SEVERAL DAYS OFF WORK OVER THE YEARS FROM HAVING ALLERGIC REACTIONS TO PRODUCTS THAT DO NOT INDICATE THEY CONTAIN SHELLFISH. THE WAY INGREDIENTS ARE LISTED ON A PRODUCT SHOULD CONTAIN ALL OF THE INGREDIENTS IN PLAIN LAYMAN'S TERMS SO THAT THE AVERAGE PERSON DOES NOT GO THROUGH THE SAME OR WORSE MISERY I'VE BEEN PUT THROUGH ON MANY OCCASIONS. PEOPLE HAVE THE RIGHT TO KNOW EXACTLY WHAT THEY ARE PURCHASING AND IF IT WILL HARM THEM. I'M NOT ASKING YOU TO WARN ME THAT COFFEE IS HOT BUT TO WARN ABOUT HARMFUL UNSEEN DANGERS. I STARTED TAKING BENADRYL THE FIRST DAY. IF I HADNT, I'M SURE THINGS WOULD HAVE BEEN MUCH WORSE. I HAD EATEN PASTA CONTAINING CAN OYSTERS BUT DIDN'T ACTUALLY CONSUME THE OYSTER THINKING IT WAS MUSHROOMS. AND YET MY THROAT STILL SWELLED SHUT AND AN AMBULANCE WAS CALLED. BEING ALLERGIC TO SHELLFISH IS NOT JOKE BUT A SCARY WAY TO LIVE IN A WORLD THAT DOES NOT LIST ALL INGREDIENTS PLAINLY. THANK YOU FOR YOUR TIME. FDA SAFETY REPORT ID # (B)(4).