Implant, dermal, for aesthetic use

Description of Event or Problem

BASED ON THE INFORMATION/REPORT PROVIDED BY A PATIENT ON (B)(6) 2023 THROUGH PROLLENIUM ANSWERCONNECT, SHE WS INJECTED WITH PROLLENIUM PRODUCTS (PRODUCT TYPE, INJECTION VOLUME AND INJECTION DATE WERE NOT DISCLOSED). SHE HAS NUMBNESS AT THE INJECTION SITE (INJECTION AREA WAS NOT DISCLOSED). AND DOES NOT WANT TO GO THE EMERGENCY. SHE IS PLANNING TO CONTACT THE CLINICAL THE NEXT MORNING. THE CLINIC NAME PROVIDED BY THE PATIENT DOES NOT EXIST IN THE PROLLENIUM DATABASE. PROLLENIUM CONDUCTED THE PATIENT MULTIPLE TIMES ((B)(6) 2023 (11:00 AM), (B)(6) 2023 (10:00 AM), (B)(6) 2023 (11:36 AM), (B)(6) 2023 (9:15 AM), (B)(6) 2023 (10:12 AM) AND (B)(6) 2023 (8:44 AM)) THROUGH THE PHONE NUMBER PROVIDED BY THE PATIENT AND LEFT MESSAGE TO HER TO GET MORE INFORMATION BUT HAS RECEIVED NO RESPONSE. SINCE THE REQUIRED INFORMATION (CLINIC NAME, THE INFORMATION ASSOCIATED WITH THE PRODUCT AND THE PATIENT) HAS NOT BEEN PROVIDED, PROLLENIUM COULD NOT COMPLETE INTERNAL INVESTIGATION (E.G. REVIEW BATCH RECORD, QC TESTING RECORDS, EMPLOYEE TRAINING RECORDS, DEVIATION LOG). HOWEVER, THE LIMITED INFORMATION PROVIDED WAS SENT TO THE PROLLENIUM MEDICAL DIRECTOR IN ORDER TO OBTAIN HIS MEDICAL OPINION ABOUT THIS CASE. THE PROLLENIUM MEDICAL DIRECTOR'S OPINION IS AS FOLLOWS: "THE FOLLOWING IS A CLINICAL OPINION BASED ON THE INFORMATION PROVIDED IN CASE (B)(4). ON (B)(6) 2023 AT 5:09 PM, A PATIENT LEFT A MESSAGE ON ANSWERCONNECT CLAIMING SHE HAD "NUMBNESS AT THE SITE OF HER INJECTION". THE TIME AND AREA OF INJECTION, AS WELL AS THE PRODUCT USED WERE NOT DISCLOSED. THE PATIENT WAS PLANNING TO CONTACT THE CLINICAL THE NEXT MORNING. THE CLINIC NAME PROVIDED DOES NOT APPEAR TO EXIST. THE PATIENT WOULD NOT RESPOND TO ATTEMPTS TO GET FATHER INFORMATION. AS THERE IS NO CLINICAL INFORMATION AND THE PATIENT DECLINED FURTHER CONTACT IT IS ASSUMED THAT THE CONCERN RESOLVED AND THAT THE TREATING CLINIC DID NOT THINK THIS WAS AN ADVERSE EVENT"..

Additional Manufacturer Narrative

THE REQUIRED INFORMATION (E.G. LOT NUMBER, THE INFORMATION ASSOCIATED WITH THE PRODUCT AND THE PATIENT, CLINIC NAME, TREATMENT PLAN) HAS NOT BEEN PROVIDED. THEREFORE INTERNAL INVESTIGATION COULD NOT BEEN COMPLETED. THE LIMITED INFORMATION PROVIDED WAS SENT TO THE PROLLENIUM MEDICAL DIRECTOR IN ORDER TO OBTAIN HIS MEDICAL OPINION ABOUT THIS CASE. THE PROLLENIM MEDICAL DIRECTOR'S OPINION IS AS FOLLOWS: " "THE FOLLOWING IS A CLINICAL OPINION BASED ON THE INFORMATION PROVIDED IN CASE (B)(4). ON (B)(6) 2023 AT 5:09 PM, A PATIENT LEFT A MESSAGE ON ANSWERCONNECT CLAIMING SHE HAD "NUMBNESS AT THE SITE OF HER INJECTION". THE TIME AND AREA OF INJECTION, AS WELL AS THE PRODUCT USED WERE NOT DISCLOSED. THE PATIENT WAS PLANNING TO CONTACT THE CLINICAL THE NEXT MORNING. THE CLINIC NAME PROVIDED DOES NOT APPEAR TO EXIST. THE PATIENT WOULD NOT RESPOND TO ATTEMPTS TO GET FATHER INFORMATION. AS THERE IS NO CLINICAL INFORMATION AND THE PATIENT DECLINED FURTHER CONTACT IT IS ASSUMED THAT THE CONCERN RESOLVED AND THAT THE TREATING CLINIC DID NOT THINK THIS WAS AN ADVERSE EVENT".