OPTIVIEW
Received Oct 18, 2019
Report 8031023-2019-00001 · MDR key 9206080
Device
Product problems
- Appropriate Device Problem Term/Code Not Available
- Appropriate Device Problem Term/Code Not Available
Patient
Not reported
- No Code Available
- No Code Available
Narrative
Additional Manufacturer Narrative
PATIENT WENT TO THE EMERGENCY ROOM WHERE PATIENT RECEIVED INTRAMUSCULAR INJECTION OF STEROID. ADDITIONALLY, PATIENT RECEIVED ORAL STEROID ENCORTON, SOLCOSERYL FOR LUBRICATION AND THE RINSE ELUDRIL. CURRENTLY PATIENT IS DOING WELL AND HAS NO COMPLAINTS. 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 FIRST OF TWO REPORTS.