NOT CONFIRMED
Received Oct 18, 2024 · Event occurred Sep 14, 2024
Report 3004423487-2024-00021 · MDR key 20486690
Device
Product problems
- Adverse Event Without Identified Device or Use Problem
- Adverse Event Without Identified Device or Use Problem
Patient
NA · Male
- Swelling/ Edema
- Swelling/ Edema
Narrative
Description of Event or Problem
ADVERSE EVENT INFORMATION: THE PATIENT REACHED OUT TO PROLLENIUM MEDICAL VIA ITS ANSWER CONNECT LINE TO REPORT THE ADVERSE EVENT, PATIENT REPORTS HAVING SWELLING ON ONE SIDE OF THE FACE. ON FOLLOW UP CALLS, PATIENT HAS CONFIRMED TO PROLLENIUM ON REACHING OUT TO THE INJECTOR AND REPORTS THAT THE ADVERSE EVENTS HAVE IMPROVED SIGNIFICANTLY. PROLLENIUM HAS REACHED OUT TO THE INJECTOR/CLINIC MULTIPLE TIME TO OBTAIN MORE INFORMATION TO CONDUCT A THROUGH INVESTIGATION HOWEVER NO RESPONSE WAS PROVIDED. PROLLENIUM WAS NOT ABLE TO CONFIRM IF THIS IS AN ADVERSE EVENT ASSOCIATED WITH A REVANESSE PRODUCT.
Additional Manufacturer Narrative
NO INFORMATION WAS PROVIDED BY THE INJECTOR OR CLINIC TO COMPLETE AN INVESTIGATION.
Remedial action
- Patient Monitoring