REVANESSE VERSA+ (WITH LIDOCAINE)

Description of Event or Problem

POST-INJECTION, PATIENT DEVELOPED A FEVER AND A HARD PLACE IN THE CHEEK WITH 1 ML OF 1.2 ML SYRINGE OF VERSA. VERSA WAS INJECTED USING A 27 G ½ IN NEEDLE INCLUDED IN THE FILLER PACKAGE, AND THEN SWITCHED TO AN ALLERGAN MICRO-CANNULA AND PUNCH NEEDLE. VERSA WAS INJECTED IN AN AREA OF VOLUME DEPLETION. THIS AREA BECAME VOLUME DEPLETED AFTER AN ADVERSE REACTION WITH VOLUMA A NUMBER OF YEARS AGO. SINCE THAT TIME, PATIENT HAS BEEN INJECTED IN THIS AREA WITH MULTIPLE FILLERS AND BY MULTIPLE INJECTORS THE MICRO-CANNULA WAS REMOVED AND THE OTHER, NEW 27G 1/2IN NEEDLE WAS PLACED ON THE SYRINGE. THEN AN INJECTION WAS ATTEMPTED; HOWEVER, BLOOD WELLED UP AND THE INJECTION WAS STOPPED. PRESSURE WAS APPLIED. ONCE HEMOSTASIS WAS ACHIEVED, CAPILLARY REFILL WAS CHECKED AND NORMAL. THE PATIENT'S FINGER WAS CLEANSED WITH RUBBING ALCOHOL, AND SHE FELT THE FIRM AREA OVER THE HEMATOMA. PATIENT WAS SEEN IN THE ER THAT EVENING, AND PLACED ON ANTIBIOTICS, AND CORTICOSTEROIDS. MNAUFACTURER MEDICAL DIRECTOR OPINION: ON (B)(6) 2023, A PATIENT RECEIVED 1.0 CC OF REVEANESSE VERSA + INTO HER LEFT SUBMALAR HALLOW WHICH WAS CREATED BY A PREVIOUS NODULAR REACTION TO VOLUMA FILLER. THE PATIENT GIVES A HISTORY OF NODULAR REACTIONS TO VOBELLA IN HER LIPS AND VOLLURE IN HER ORAL COMMISSURES AND CHIN. THE PATIENT DESCRIBES HERSELF AS BEING ALLERGIC TO "VYCROSS" AND ARNICA. THIS HISTORY CREATES A CONTRAINDICATION TO ANY HA FILLER IN ANY OF THESE AREAS AS MOST HA FILLER USE BBDE AS A CROSS LINKING AGENT. DURING THE INJECTION, WHICH INVOLVED THE USE OF NEEDLE AND MICRO CANNULA, THE INJECTOR REPORTS THAT " BLOOD WELLED UP" AND THE PROCEDURE WAS STOPPED TO GET CONTROL OF THE BLEEDING. THE INJECTOR DESCRIBES A LARGE FIRM HEMATOMA IN THE AREA OF INJECTION. THE PATIENT WAS SENT HOME WITH NO FURTHER TREATMENT OF THE AREA AND AT HOME TOOK IBUPROFEN WHICH IS ALSO CONTRAINDICATED IMMEDIATELY AFTER HAEMORRHAGING AND HEMATOMA. THE PATIENT WAS SEEN IN ER THAT EVENING AND WAS TREATED WITH ANTIBIOTICS AND ORAL CORTICOSTERIODS. NO DIAGNOSIS WAS PROVIDED. THE PATIENT WAS NOT SEEN AGAIN BY THE TREATING CLINIC HOWEVER WAS SEEN BY "MULTIPLE PHYSICIANS" FOR THIS ISSUE. ONCE AGAIN NO HISTORY OF THESE ENCOUNTERS WAS PROVIDED. THE PHOTOS PROVIDED SHOW AREAS OF ERYTHEMA AND BRUISING ON BOTH SUBMALAR AREAS. WHEN THESE PHOTOS WERE TAKEN WAS NOT PROVIDED. MY CLINICAL OPINION IS THAT THIS CASE REPRESENTS SIGNIFICANT BRUISING CAUSED BY A SUB OPTIMAL INJECTION IN A PATIENT WHO HAS OBVIOUS CONTRADICTIONS TO RECEIVING FILLER INTO THE AREA THAT WAS BEING INJECTED.