REVANESSE VERSA

Description of Event or Problem

THE MANUFACTURER WAS NOTIFIED BY ITS US AGENT, PATIENT HAS SUBMITTED A MEDWATCH REPORT MW5171329 TO THE FDA. THE MDR REPORT DETAILS THAT THE PATIENT (UNKNOWN) 40 YEARS, FEMALE, 64KG, NON-HISPANIC, WHITE WAS INJECTED WITH REVANESSE VERSA 1ML PER CHEEK, IN 2021. PATIENT REPORTS THAT SHE BEGAN HAVING EXTREME FACIAL PAIN IN CHEEKS AND FEELINGS OF HEAVINESS IN 2024. ULTRASOUND IMAGES CONFIRMED THAT THE PRODUCT WAS PRESENT AND DID NOT DISSOLVE WITHIN 6-12 MONTHS LIKE IT WAS SUPPOSED TO. THE PATIENT REPORTS THAT HER ONLY OPTION WAS TO DISSOLVE IT WITH HYLENEX, AND REPORTS HAVING DEVELOPED A BAD REACTION TO AS WELL. "THE FIRST ROUND OF DISSOLVER DIDN'T COMPLETELY REMOVE THE PRODUCT AND NOW I HAVE NO WAY TO GET RID OF IT". OWING TO THE LIMITED INFORMATION PROVIDED IN THE MDR REPORT, THE MANUFACTURER IS NOT ABLE TO COMPLETE A SUITABLE INVESTIGATION OF THE BATCH PRODUCTION HISTORY. MEDICAL ASSESSEMENT IS PROVIDED BY PMT'S MEDICAL DIRECTOR IS BELOW: MEDICAL ASSESSMENT: THE FOLLOWING IS A CLINICAL OPINION BASED ON THE LIMITED INFORMATION PROVIDED BY A PATIENT TO THE FDA IN CASE (B)(4) (MW5171329). SOME TIME IN 2021 A PATIENT ALLEGEDLY (NO LOT NUMBER OR INJECTING CLINIC NAME TO CONFIRM PURCHASE) RECEIVED 1.0 CC OF REVANESSE VERSA IN EACH " CHEEK". THERE WERE NO CONCERNS OR ADVERSE EVENTS AT THE TIME OF INJECTION. THREE YEARS LATER IN 2024 THE PATIENT BEGAN HAVING " FACIAL PAIN" AND " A FEELING OF HEAVINESS" (AN UNDEFINED, SUBJECTIVE NON-CLINICAL TERM). THERE IS NO HISTORY OR RECORD OF THE PATIENT HAVING A MEDICAL ASSESSMENT WHICH WOULD BE CRITICALLY IMPORTANT AS THE DIFFERENTIAL DIAGNOSIS OF "FACIAL PAIN" IS EXTENSIVE. THE PATIENT RECEIVED HYLENEX HYLURONIDASE IN 2024. TEN MONTHS LATER THE PATIENT REPORTED THE EVENTS TO THE FDA. THERE IS STILL NO HISTORY OF A MEDICAL ASSESSMENT, DIAGNOSIS OR CURRENT PATIENT CONDITION. ALTHOUGH IT IS IMPOSSIBLE TO FORM A MEDICAL OPINION BASED ON A PAUCITY OF INFORMATION, IT IS HIGHLY IMPLAUSIBLE THAT 24 MG OF BIO-SIMILAR HA WOULD NOT BE COMPLETELY, DISPERSED, INTEGRATED OR DISSOLVED AFTER 3 YEARS. I SEE NO EVIDENCE THAT THIS CASE REPRESENTS AN ADVERSE EVENT TO INJECTABLE HA. I WOULD RECOMMEND THAT THE PATIENT SEEKS A MEDICAL OPINION TO DETERMINE THE CAUSE OF HER FACIAL PAIN, IF IT STILL PERSISTS.