REVANESSE VERSA

Additional Manufacturer Narrative

PATIENT WAS INJECTED WITH DYSPORT AND REVANESSE VERSA INTO THE GLABELLAR RHYTIDES . PATIENT CONTACTED INJECTOR AND INDICATED SHE WAS HAPPY WITH THE TREATMENT (B)(6) 2019. ON (B)(6) 2019 PATIENT CALLED AND COMPLAINED OF SWELLING IN HER FOREHEAD. DURING PATIENT APPOINTMENT ON (B)(6) 2019 VITRASE (200U) INJECTED TO GLABELLAR AREAS. KEFLEX X500 MG TID PRESCRIBED FOR 10 DAYS. ON THE (B)(6) 2019 RESTYLANE INJECTED INTO NL FOLDS, GLABELLAR REGION HAD IMPROVED. ON (B)(6) 2019 THE PATIENT RETURNED WITH INFLAMMED-LIVEDO-BLANCHING. MEDROL DOSE PACK WAS PRESCRIBED WITH DOXYCYCLINE 100 MG BID. ADDITIONALLY, VITRASE 100U INJECTED. THE PATIENT WAS RECOMMENDED BY THE INJECTOR TO SEE DERMATOLOGIST/PLASTIC SURGEON IN THE CASE OF NO RESOLUTION. IN SUMMARY, THE COMPLAINT STATES THAT AN ADVERSE REACTION ENSUED THAT WAS PERSISTENT AND HAS NOT GONE AWAY DESPITE FOLLOW UP VISITS TO A DERMATOLOGIST AND A PLASTIC SURGEON. PATIENT MADE AN APPOINTMENT WITH A RHEUMATOLOGIST TO RULE OUT ANY AUTOIMMUNE ISSUES. PATIENT UNDERWENT DRAINING OF PURULENCE IN THE OFFICES OF THE INITIAL INJECTOR AND DERMATOLOGIST. INITIAL INJECTOR INDICATED THAT THE CONDITION OF THE PATIENT APPEARED TO IMPROVED FOLLOWING A COURSE OF DOXYCYCLINE 100 MG. PATIENT CONTINUED TO RECEIVE NASOLABIAL AND LIP INJECTIONS WITHOUT ANY ADVERSE EVENTS IN (B)(6) 2020 PATIENT VISITED INJECTOR REQUESTED INJECTION WITH DYSPORT INTO GLABELLAR FRONTALIS AREA AND REQUESTED ANOTHER TREATMENT IN (B)(6) 2020. PATIENT RELAYED TO INJECTOR THAT "THE AREA SEEMS BETTER WHEN I HAVE DYSPORT". THE RETROSPECTIVE REVIEW OF THE BATCH FILE SHOWS THAT NO ELEMENT COULD EXPLAIN THE ADVERSE EVENTS DESCRIBE. THE SYRINGES RELATED TO THE COMPLAINT LOT WERE PREPARED FROM A MANUFACTURING BATCH WHICH PASSED ALL QC TESTING AND 100% VISUAL INSPECTION OF FILLED SYRINGES. A REVIEW OF THE PACKAGING DOCUMENTATION AND FINAL RELEASE CRITERIA INDICATES THAT THE REVANESSE VERSA (LOT# 18K003) WAS MANUFACTURED WITHIN SPECIFICATION. THE MEDICAL OPINION THE MANUFACTURER'S MEDICAL DIRECTOR IS THAT THE NODULE IS CENTRAL WHILE THE SMALL AMOUNT OF HA WAS INJECTED INTO THE RHYTIDES, WHICH ARE SUPERFICIAL AND LATERAL TO THIS AREA. IT IS UNLIKELY THE PRODUCT WOULD NOT BE IN THIS CENTRAL AREA UNLESS INJECTED SUBDERMALLY AND TRACKED TO THE AREA VIA MUSCULAR CONTRACTION.

Description of Event or Problem

PATIENT WAS INJECTED WITH DYSPORT AND REVANESSE VERSA INTO THE GLABELLAR RHYTIDES . PATIENT CONTACTED INJECTOR AND INDICATED SHE WAS HAPPY WITH THE TREATMENT (B)(6) 2019. ON (B)(6) 2019 PATIENT CALLED AND COMPLAINED OF SWELLING IN HER FOREHEAD. DURING PATIENT APPOINTMENT ON (B)(6) 2019 VITRASE (200U) INJECTED TO GLABELLAR AREAS. KEFLEX X500 MG TID PRESCRIBED FOR 10 DAYS. ON THE (B)(6) 2019 RESTYLANE INJECTED INTO NL FOLDS, GLABELLAR REGION HAD IMPROVED. ON (B)(6) 2019 THE PATIENT RETURNED WITH INFLAMMED-LIVEDO-BLANCHING. MEDROL DOSE PACK WAS PRESCRIBED WITH DOXYCYCLINE 100 MG BID. ADDITIONALLY, VITRASE 100U INJECTED. THE PATIENT WAS RECOMMENDED BY THE INJECTOR TO SEE DERMATOLOGIST/PLASTIC SURGEON IN THE CASE OF NO RESOLUTION. IN SUMMARY, THE COMPLAINT STATES THAT AN ADVERSE REACTION ENSUED THAT WAS PERSISTENT AND HAS NOT GONE AWAY DESPITE FOLLOW UP VISITS TO A DERMATOLOGIST AND A PLASTIC SURGEON. PATIENT MADE AN APPOINTMENT WITH A RHEUMATOLOGIST TO RULE OUT ANY AUTOIMMUNE ISSUES. PATIENT UNDERWENT DRAINING OF PURULENCE IN THE OFFICES OF THE INITIAL INJECTOR AND DERMATOLOGIST. INITIAL INJECTOR INDICATED THAT THE CONDITION OF THE PATIENT APPEARED TO IMPROVED FOLLOWING A COURSE OF DOXYCYCLINE 100 MG. PATIENT CONTINUED TO RECEIVE NASOLABIAL AND LIP INJECTIONS WITHOUT ANY ADVERSE EVENTS IN (B)(6) 2020 PATIENT VISITED INJECTOR REQUESTED INJECTION WITH DYSPORT INTO GLABELLAR FRONTALIS AREA AND REQUESTED ANOTHER TREATMENT IN (B)(6) 2020. PATIENT RELAYED TO INJECTOR THAT "THE AREA SEEMS BETTER WHEN I HAVE DYSPORT".