inforMED
MalfunctionLMH

REVANESSE VERSA

Received Jul 18, 2019 · Event occurred Nov 6, 2018

Report 3004423487-2019-00008 · MDR key 8802606

Device

Generic name

Revanesse Versa

Model number

40081

Lot 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.