InjuryEIG
OPTIVIEW SMALL KIT
Received Feb 8, 2021
Report 8031023-2016-00003 · MDR key 11298472
Device
Product problems
- Patient-Device Incompatibility
- Patient-Device Incompatibility
Patient
35 YR
- Hypersensitivity/Allergic reaction
- Pain
- Ulcer
- Swelling/ Edema
- Hypersensitivity/Allergic reaction
- Pain
- Ulcer
- Swelling/ Edema
Narrative
Additional Manufacturer Narrative
THE SYMPTOMS WERE TREATED WITH BENTELAN. TO DATE, THE PATIENT IS DOING FINE. THE PRODUCT WAS NOT RETURNED AND NO LOT NUMBER WAS PROVIDED; THEREFORE, NO EVALUATION WAS CONDUCTED.
Description of Event or Problem
A DENTIST INDICATED TWO (2) PATIENTS EXPERIENCED AN ALLERGIC REACTION RESULTING IN SWOLLEN LIPS, PAIN, AND ULCERS APPROXIMATELY TWO HOURS AFTER TREATMENT INVOLVING OPTIVIEW SMALL KIT. THIS IS THE SECOND OF TWO REPORTS.