REVANESSE VERSA+ WITH LIDOCAINE
Received Jul 10, 2020 · Event occurred Jun 11, 2020
Report 3004423487-2020-00007 · MDR key 10260941
Device
Generic name
Revanesse Versa+ With Lidocaine
Manufacturer
Prollenium Medical Technologies Inc.Model number
PN40083Lot number
19J057
Product problems
- Adverse Event Without Identified Device or Use Problem
Patient
Not reported
- Bruise/Contusion
- Itching Sensation
- Reaction
- Bruise/Contusion
- Itching Sensation
- Reaction
Narrative
Additional Manufacturer Narrative
PATIENT WAS INJECTED REVANESSE VERSA+ WITH LIDOCAINE (19J057) INTO NASOLABIAL FOLDS IN (B)(6) 2020. PATIENT PRESENTED WITH 2 - ITCHY, NON - TENDER NODULES UNDER SKIN APPROXIMATELY 1-2 DAYS POST INJECTION. BOTH NODULES ON ONE SIDE WITH SOME BRUISING. ACCORDING TO MEDICAL DIRECTOR IT IS A REACTION TO CHLORHEXIDINE PREPARATION BUT THE MEDICAL DIRECTOR WANTED TO CHECK BEFORE REVERSING WITH HYLENEX. IT SEEMS TOO CLOSE TO PROCEDURE TO BE INFECTION. THE BATCH RECORD AND TEST REPORT FOR THE LOT 19J057 WERE CHECKED AND VERIFIED. THE CERTIFICATE OF ANALYSIS, MANUFACTURING BATCH RECORD CHECKLIST, QUALITY CONTROL TEST REPORT AND PACKAGING DOCUMENTS WERE CHECKED AND DID NOT FIND ANY IRREGULARITIES IN THE RECORDS. ALL THE RECORDS WERE IN COMPLIANCE WITH THE STANDARDS SPECIFICATIONS AND PRODUCT HAS PASSED. THERE IS NO DEVIATION OR NCR WAS ASSOCIATED WITH THIS LOT. ACCORDING TO THE INJECTOR AND MANUFACTURER'S MEDICAL DIRECTOR'S ASSESSMENT, THE ALLERGIC REACTIONS WERE MAINLY DUE TO THE CHLORHEXIDINE TOPICAL DISINFECTANT. THE INJECTOR INFORMED TO THE MANUFACTURER'S QUALITY DEPARTMENT THAT THE PRURITUS HAS RESOLVED AND THE PATIENT IS HAPPY WITH THE RESULT.
Description of Event or Problem
PATIENT WAS INJECTED REVANESSE VERSA+ WITH LIDOCAINE (19J057) INTO NASOLABIAL FOLDS IN (B)(6) 2020. PATIENT PRESENTED WITH 2 - ITCHY, NON - TENDER NODULES UNDER SKIN APPROXIMATELY 1-2 DAYS POST INJECTION. BOTH NODULES ON ONE SIDE WITH SOME BRUISING. ACCORDING TO MEDICAL DIRECTOR IT IS A REACTION TO CHLORHEXIDINE PREPARATION BUT THE MEDICAL DIRECTOR WANTED TO CHECK BEFORE REVERSING WITH HYLENEX. IT SEEMS TOO CLOSE TO PROCEDURE TO BE INFECTION.