MalfunctionLMH
REVANESSE VERSA
Received Jan 11, 2019 · Event occurred May 7, 2018
Report 3004423487-2019-00002 · MDR key 8242086
Device
Generic name
Dermal Filler
Manufacturer
Prollenium Medical Technologies Inc.Model number
PN40081Lot number
17L026
Product problems
- Patient-Device Incompatibility
Patient
Not reported
- Swelling
- Swelling
Narrative
Description of Event or Problem
THE NURSE (INJECTOR) HAS STATED THAT THE PATIENT WAS INJECTED WITH REVANESSE VERSA IN THE TEAR TROUGH AREA ON FRIDAY MAY 4TH (TOTAL OF 0.8CC) THE PTIENT CALLED THE NURSE BACK ON MONDAY MAY 7TH COMPLAINING OF SEVERE SWELLING.