REVANESSE VERSA+ 1.2 ML

Description of Event or Problem

AT SOME TIME APPROXIMATELY 27 MONTHS EARLIER AT PATIENT RECEIVED " REVANESSE VERSA" (UNCONFIRMED AS NO LOT # WAS PROVIDED) INTO HER LIPS BY AN RN. THERE WERE NO RECORDED ADVERSE EVENTS OR CONCERNS. TWO YEARS AND 3 MONTHS LATER THE PATIENT NOTICED A SMALL NON INFLAMED RIDGE ON HER EVERTED, INNER, UPPER LIP. THE RIDGE WAS ON THE MUCOSA IN LINE WITH THE OCCLUSION OF THE TEETH. THE LINE EVEN HAD GAPS CORRESPONDING TO THE SPACES BETWEEN THE PATIENT'S TEETH. THE INJECTOR DESCRIBED THE PATIENT AS "UNDER STRESS". THERE WAS NO MEDICAL DIRECTOR DOCUMENTED ON THE AE NOTIFICATION FORMS WHICH SUGGESTS THE PATIENT DID NOT HAVE A MEDICAL ASSESSMENT FOR HER CONCERN. MY CLINICAL OPINION IS THAT THIS DOES NOT REPRESENT AN HAVE ADVERSE EVENT. THE LINE ON THE MUCOSA OF THE UPPER LIP IS THE CLASSIC APPEARANCE SEEN WHEN SOMEONE HABITUALLY BITES ONTO THEIR LIP. THIS IS A VERY COMMON FINDING AND OCCURS MORE OFTEN WHEN INDIVIDUALS ARE NERVOUS OR STRESSED. INTERNAL REPORT NUMBER: (B)(4).