REVANESSE VERSA
Received Jul 12, 2019 · Event occurred Jun 19, 2018
Report 3004423487-2019-00005 · MDR key 8785462
Device
Generic name
Dermal Filler
Manufacturer
Prollenium Medical Technologies Inc.Model number
PN40081Lot number
17K004
Product problems
- Adverse Event Without Identified Device or Use Problem
Patient
Not reported
- Swelling
- Swelling
Narrative
Additional Manufacturer Narrative
1.CORRECTION TO SECTION E1 FROM INITIAL REPORT:- CHANGED THE MDR REPORTER COUNTRY FROM CANADA TO USA. 2. CORRECTION TO SECTION E2 FROM INITIAL REPORT:- CHANGED HEALTH PROFESSIONAL TO YES. 3. CORRECTION TO SECTION E3 FROM INITIAL REPORT:-CHANGED OCCUPATION TO NURSE PRACTITIONER.
Description of Event or Problem
PATIENT - (REFERRED AS EMPLOYEE 2 JP) : (B)(6) 2018; RECEIVED 1ML SYRINGE OF VERSA MIXED WITH 0.3ML OF 1% LIDOCAINE IN LIPS. NURSE USED 27G 1.5IN CANNULA WITH A RETROGRADE INJECTION TECHNIQUE. WITHIN 24HRS POST INJECTION JP NOTICED SIGNIFICANT INCREASE IN TISSUE SWELLING AND THE PRODUCT LOOKED LIKE IT HAS BECOME HARD LUMPS. ADVISED TO WAIT 2 WEEKS FOR SIDE EFFECTS TO SUBSIDE. (B)(6) 2018; SEVERAL AREAS REMAIN SIGNIFICANTLY SWOLLEN AND APPEAR LUMPY OR AS IF THE PRODUCT HAD BALLED UP. ATTEMPTED TO MANIPULATE PRODUCT TO SEE IF PALPATING WOULD SOFTEN THE AREAS BUT WAS UNABLE TO MANIPULATE. BOTTOM L LIP; INJECTED WITH 0.2 ML HYALURONIDASE DIRECTLY INTO THAT AREA. ALSO INJECTED 0.2ML HYALURONIDASE INTO L UPPER LIP. INJECTED 0.1ML INTO R UPPER LIP. (B)(6) 2018; SWELLING IN AREAS TREATED WITH HYALURONIDASE HAD DECREASED, HOWEVER, R LOWER LIP STILL WITH SIGNIFICANT SWELLING. INJECTED 0.2ML HYALURONIDASE IN R LOWER LIP. INJECTED 0.15ML INTO L LOWER LIP AND 0.1ML INTO R UPPER LIP. INJECTED L UPPER LIP WITH 0.05ML. (B)(6) 2018; JP STILL HAS NOTICEABLE BUMP IN R LOWER LIP AND SMALL RAISED RIDGE TO L LOWER LIP AFTER 2 INJECTIONS WITH HYALURONIDASE.