REVANESSE VERSA+ (WITH LIDOCAINE)

Additional Manufacturer Narrative

THE NURSE INJECTOR INJECTED 0.6 ML REVANESSE VERSA+ WITH LIDOCAINE (20B034) VIA CANNULA AND NEEDLE INSERTION INTO HER VERMILLION LIPS AND 0.2 ML INTO MARIONETTE LINES WITH TOPICAL ANESTHESIA 20% LIDOCAINE/ 10% TETRACAINE/ 10% TETRACAINE GEL ON (B)(6) 2020. TOPICAL ANESTHESIA WAS APPLIED FOR 20 MIN. APPROXIMATELY 4 HOURS AFTER THE TREATMENT, PATIENT RETURNED TO CLINIC TO RULE OUT VASCULAR OCCLUSION. PATIENT'S LIPS HAD TRIPLED IN SIZE SINCE POST INJECTION WHERE NO RED FLAGS SUCH AS PAIN, BLANCHING, OR VASCULAR COMPROMISE WERE PRESENT. LIPS WERE RED AND WARM TO THE TOUCH WITH GOOD CAP REFILL AND NO APPARENT VASCULAR COMPROMISE, REACTION SEEMED TO BE ALLERGIC IN NATURE AND PATIENT WAS INSTRUCTED TO TAKE A BENEDRYL OR ZYRTEC DAILY ALONG WITH PEPCID 20 MG FOR THE REMAINDER OF THE WEEK. NURSE INJECTOR FOLLOWED UP WITH PATIENT THAT EVENING AS WELL AS THE NEXT 3 DAYS. PATIENT SENT SWELLING IMPROVING. AFTER 2 DAYS, LIPS RETURNED TO NORMAL SIZE AND BRUISING APPARENT TO UPPER AND LOWER LIP. ADDITIONAL COMMENT: THE BATCH RECORD AND TEST REPORT FOR THE LOT 20B034 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.

Description of Event or Problem

THE NURSE INJECTOR INJECTED 0.6 ML REVANESSE VERSA+ WITH LIDOCAINE (20B034) VIA CANNULA AND NEEDLE INSERTION INTO HER VERMILLION LIPS AND 0.2 ML INTO MARIONETTE LINES WITH TOPICAL ANESTHESIA 20% LIDOCAINE/ 10% TETRACAINE/ 10% TETRACAINE GEL ON (B)(6) 2020. TOPICAL ANESTHESIA WAS APPLIED FOR 20 MIN. APPROXIMATELY 4 HOURS AFTER THE TREATMENT, PATIENT RETURNED TO CLINIC TO RULE OUT VASCULAR OCCLUSION. PATIENT'S LIPS HAD TRIPLED IN SIZE SINCE POST INJECTION WHERE NO RED FLAGS SUCH AS PAIN, BLANCHING, OR VASCULAR COMPROMISE WERE PRESENT. LIPS WERE RED AND WARM TO THE TOUCH WITH GOOD CAP REFILL AND NO APPARENT VASCULAR COMPROMISE, REACTION SEEMED TO BE ALLERGIC IN NATURE AND PATIENT WAS INSTRUCTED TO TAKE A BENEDRYL OR ZYRTEC DAILY ALONG WITH PEPCID 20 MG FOR THE REMAINDER OF THE WEEK. NURSE INJECTOR FOLLOWED UP WITH PATIENT THAT EVENING AS WELL AS THE NEXT 3 DAYS. PATIENT SENT SWELLING IMPROVING. AFTER 2 DAYS, LIPS RETURNED TO NORMAL SIZE AND BRUISING APPARENT TO UPPER AND LOWER LIP.

Additional Manufacturer Narrative

THE NURSE INJECTOR INJECTED 0.6 ML REVANESSE VERSA+ WITH LIDOCAINE (20B034) VIA CANNULA AND NEEDLE INSERTION INTO HER VERMILLION LIPS AND 0.2 ML INTO MARIONETTE LINES WITH TOPICAL ANESTHESIA 20% LIDOCAINE/ 10% TETRACAINE/ 10% TETRACAINE GEL ON (B)(6) 2020. TOPICAL ANESTHESIA WAS APPLIED FOR 20 MIN. APPROXIMATELY 4 HOURS AFTER THE TREATMENT, PATIENT RETURNED TO CLINIC TO RULE OUT VASCULAR OCCLUSION. PATIENT'S LIPS HAD TRIPLED IN SIZE SINCE POST INJECTION WHERE NO RED FLAGS SUCH AS PAIN, BLANCHING, OR VASCULAR COMPROMISE WERE PRESENT. LIPS WERE RED AND WARM TO THE TOUCH WITH GOOD CAP REFILL AND NO APPARENT VASCULAR COMPROMISE, REACTION SEEMED TO BE ALLERGIC IN NATURE AND PATIENT WAS INSTRUCTED TO TAKE A BENEDRYL OR ZYRTEC DAILY ALONG WITH PEPCID 20 MG FOR THE REMAINDER OF THE WEEK. NURSE INJECTOR FOLLOWED UP WITH PATIENT THAT EVENING AS WELL AS THE NEXT 3 DAYS. PATIENT SENT PHOTOS OF SWELLING IMPROVING. AFTER 2 DAYS, LIPS RETURNED TO NORMAL SIZE AND BRUISING APPARENT TO UPPER AND LOWER LIP. ADDITIONAL COMMENT: THE BATCH RECORD AND TEST REPORT FOR THE LOT 20B034 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.

Description of Event or Problem

THE NURSE INJECTOR INJECTED 0.6 ML REVANESSE VERSA+ WITH LIDOCAINE (20B034) VIA CANNULA AND NEEDLE INSERTION INTO HER VERMILLION LIPS AND 0.2 ML INTO MARIONETTE LINES WITH TOPICAL ANESTHESIA 20% LIDOCAINE/ 10% TETRACAINE/ 10% TETRACAINE GEL ON (B)(6) 2020. TOPICAL ANESTHESIA WAS APPLIED FOR 20 MIN. APPROXIMATELY 4 HOURS AFTER THE TREATMENT, PATIENT RETURNED TO CLINIC TO RULE OUT VASCULAR OCCLUSION. PATIENT'S LIPS HAD TRIPLED IN SIZE SINCE POST INJECTION WHERE NO RED FLAGS SUCH AS PAIN, BLANCHING, OR VASCULAR COMPROMISE WERE PRESENT. LIPS WERE RED AND WARM TO THE TOUCH WITH GOOD CAP REFILL AND NO APPARENT VASCULAR COMPROMISE, REACTION SEEMED TO BE ALLERGIC IN NATURE AND PATIENT WAS INSTRUCTED TO TAKE A BENEDRYL OR ZYRTEC DAILY ALONG WITH PEPCID 20 MG FOR THE REMAINDER OF THE WEEK. NURSE INJECTOR FOLLOWED UP WITH PATIENT THAT EVENING AS WELL AS THE NEXT 3 DAYS. PATIENT SENT PHOTOS OF SWELLING IMPROVING. AFTER 2 DAYS, LIPS RETURNED TO NORMAL SIZE AND BRUISING APPARENT TO UPPER AND LOWER LIP.