COE-SOFT
Received Aug 28, 2024 · Event occurred Jun 3, 2024
Report MW5159016 · MDR key 20098541
Device
Generic name
Resin, Denture, Relining, Repairing, Rebasing
Manufacturer
Gc America, Inc.Model number
344011Patient
NA · Unknown
- Hypersensitivity/Allergic reaction
- Skin Inflammation/ Irritation
- Swelling/ Edema
- Hypersensitivity/Allergic reaction
- Skin Inflammation/ Irritation
- Swelling/ Edema
Narrative
Description of Event or Problem
PATIENT HAD AN ALLERGIC REACTION TO A MEDICATION OF OURS (COE SOFT). THE PATIENT EXPERIENCED A SWOLLEN LIP AND IRRITATION AFTER USE OF THE PRODUCT. THE DOCTOR CALLED TO GET THE INGREDIENTS IN COE SOFT BECAUSE THE PATIENT WENT TO THE ER WITH A SWOLLEN LIP AND IRRITATION OF THE PRODUCT. THE DOCTOR INDICATED THAT THE PATIENT DID NOT EXPERIENCE AN ISSUE UNTIL 3 DAYS AFTERWARDS. THE DOCTOR ADMITTED THAT THEY USED AN EXPIRED PRODUCT. THE PRODUCT EXPIRED IN MARCH 2011. THE DOCTOR INDICATED THAT THE PATIENT WAS DOING WELL AND THAT THE SWELLING WENT DOWN WITH THE USE OF BENADRYL.