REVANESSE LIPS+ 1.2 ML
Received Apr 24, 2023 · Event occurred Mar 22, 2023
Report 3004423487-2023-00008 · MDR key 16797223
Device
Generic name
Revanesse Lips+
Manufacturer
Prollenium Medical Technologies Inc.Model number
40149Lot number
22J084
Product problems
- Adverse Event Without Identified Device or Use Problem
- Adverse Event Without Identified Device or Use Problem
Patient
27 YR · Female
- Bruise/Contusion
- Bruise/Contusion
Narrative
Description of Event or Problem
ON MARCH (B)(6) A PATIENT RECEIVED 0.8CC OF REVANESSE LIPS + INTO HER LIPS. COMPOUNDED HIGH DOSE BLT TOPICAL ANESTHETIC WAS APPLIED TO THE LIPS PRIOR TO INJECTION. THE PATIENT WAS ALSO CONCURRENTLY TAKING EXCEDRIN MIGRAINE WHICH CONTAINS, ASA, TYLENOL AND CAFFEINE. THIS MEDICATION WOULD CAUSE THE PATIENT TO HAVE AN INCREASED BRUISING RISK. DURING THE INJECTION THE INJECTOR FELT THE PATIENT DEVELOPED AN "IMMEDIATE NODULE" IN HER UPPER RIGHT LIP. COLD COMPRESSES AND OBSERVATION WAS EMPLOYED AND THE "NODULE" RESOLVED SPONTANEOUSLY WITH NO TREATMENT. THE POST PHOTOS CLEARLY SHOW A SWOLLEN BRUISE IN THE REFERENCED AREA. MY CLINICAL OPINION IS THAT THIS REPRESENTS A BRUISE SECONDARY TO A NEEDLE INJECTION INTO THE LIP. BEING ON ASA INCREASES THE LIKELIHOOD OF THIS OCCURRING. INTERNAL REPORT NUMBER: (B)(4).