OPTIVIEW
Received Oct 18, 2019
Report 8031023-2019-00002 · MDR key 9206083
Device
Product problems
- Appropriate Device Problem Term/Code Not Available
- Appropriate Device Problem Term/Code Not Available
Patient
12 YR
- No Code Available
- No Code Available
Narrative
Additional Manufacturer Narrative
PATIENT EXPERIENCED SYMPTOMS OF PAIN, BURNING DISCOMFORT, SWOLLEN LIPS. PATIENT WAS RECOMMENDED TO THE EMERGENCY ROOM AND RECEIVED ORAL STEROID AS WELL AS ANTIHISTAMINE. AFTER ONE WEEK, SWELLING DISAPPEARED. SPECIFIC PATIENT INFORMATION WITH REGARDS TO ETHNICITY, RACE AND WEIGHT WAS NOT PROVIDED. NO LOT NUMBER WAS PROVIDED THEREFORE MANUFACTURE DATE CANNOT BE DETERMINED. THE PRODUCT WAS NOT RETURNED AND NO LOT NUMBER OR PART NUMBER WAS PROVIDED; THEREFORE, NO EVALUATION CAN BE CONDUCTED.
Description of Event or Problem
A COMPLAINANT ALLEGED THAT TWO (2) PATIENTS EXPERIENCED AN ALLERGIC REACTION RESULTING IN SWELLINGS, BURNING AND PAIN IN LIPS. THIS IS THE SECOND OF TWO REPORTS.