REVANESSE VERSA
Received Jul 18, 2019 · Event occurred Nov 6, 2018
Report 3004423487-2019-00008 · MDR key 8802606
Device
Generic name
Revanesse Versa
Manufacturer
Prollenium Medical Technologies IncModel number
40081Lot number
17K004
Product problems
- Patient-Device Incompatibility
Patient
32 YR
- Swelling
- Swelling
Narrative
Description of Event or Problem
THE PATIENT RECEIVED 0.85 CC VERSA WITH NO LIDOCAINE IN LIPS ON (B)(6) 2018 AND REPORTED THAT SHE HAD LIP SWELLING ON (B)(6) 2018. LOT # 17K004 EXPIRATION OF DATE JAN 2019. PATIENT HAS HAD PREVIOUS LIP FILLER WITH RESTYLANE REFYNE ON (B)(6) 2017 IN LIPS, 0.5 CC WITH NO PROBLEMS. SHE IS A YOUNG (B)(6) YEAR OLD FEMALE WITH NO MEDICAL ISSUES AND HAS BEEN RECEIVING DYSPORT EVERY 6 MONTHS AND FILLER EVERY YEAR. SWELLING IS ONLY IN UPPER LIPS EVEN THOUGH BOTH UPPER AND BOTTOM LIPS WERE INJECTED. SHE REPORTED RECENTYL, I.E. WITHIN THE LAST 2 WEEKS, THAT HER LIPS STARTED TO SWELL AGAIN AND WAS ADVISED TO TAKE ANTIHISTAMINE OVER THE COUNTER AND THE SWELLING HAS IMPROVED. SHE HAS NOT HAD ANY LIP FILLER SINCE (B)(6) 2018.