MalfunctionEGD
WALGREENS ORTHO WX 2PK
Received Sep 9, 2019 · Event occurred Aug 15, 2019
Report 1825660-2019-00612 · MDR key 8976125
Device
Product problems
- Patient-Device Incompatibility
Patient
Not reported
- Hypersensitivity/Allergic reaction
- Itching Sensation
- Swelling
- Hypersensitivity/Allergic reaction
- Itching Sensation
- Swelling
Narrative
Description of Event or Problem
CONSUMER USED THE ORTHODONTIC WAX AND CLAIMS SHE HAD AN ALLERGIC REACTION, SHE HAD ITCHING/SWELLING. CONSUMER FOLLOWED UP SAYING THAT SHE CAN'T PINPOINT WHETHER OR NOT THIS REACTION WAS RELATED TO THE PRODUCT AS SHE'S BEEN HAVING A LOT OF "DIFFERENT ALLERGIC THINGS GOING ON." SHE SAID "THE PROBLEM STOPPED. I SWITCHED TO ANOTHER BRAND. IT MAY OR NOT HAVE BEEN THE PRODUCT. I WAS MORE CURIOUS ABOUT THE INGREDIENTS."