REVANESSE LIPS+

Description of Event or Problem

BASED ON THE INFORMATION PROVIDED, THE PATIENT GOT INJECTED WITH REVANESSE LIPS+ (WITH LIDOCAINE) IN THE LIPS AREA OF THE PATIENT ON (B)(6) 2022. AMOUNT OF PRODUCT INJECTED WAS 0.1 ML ACCORDING TO THE INITIAL REPORT. PATIENT IS FEMALE; DATE OF BIRTH IS (B)(6) . ACCORDING TO THE INITIAL REPORT, THE PATIENT WAS EXPERIENCING ALLERGIC REACTION. NO INFORMATION REGARDING TOPIC ANAESTHETIC HAS BEEN PROVIDED. NO INFORMATION REGARDING ALLERGIES HAS BEEN PROVIDED. NO INFORMATION REGARDING MEDICAL HISTORY AND PRESENCE OF RISK FACTORS HAVE BEEN PROVIDED. ON 21 JAN 2022, SAME DAY OF NOTIFICATION, QA DEPARTMENT AT PROLLENIUM MEDICAL TECHNOLOGIES CONTACTED CLINIC/INJECTOR REQUESTING INFORMATION REGARDING THIS CLINICAL COMPLAINT. ON 28 JAN 2022, AS A RESULT OF NO RESPONSE, QA DEPARTMENT AT PROLLENIUM MEDICAL TECHNOLOGIES CONTACTED CLINIC/INJECTOR AGAIN REQUESTING INFORMATION REGARDING THIS CLINICAL COMPLAINT. ON 07 FEB 2022, AS A RESULT OF NO RESPONSE, QA DEPARTMENT AT PROLLENIUM MEDICAL TECHNOLOGIES CONTACTED CLINIC/INJECTOR AGAIN REQUESTING INFORMATION REGARDING THIS CLINICAL COMPLAINT. ON 17 FEB 2022, AS A RESULT OF NO RESPONSE, QA DEPARTMENT AT PROLLENIUM MEDICAL TECHNOLOGIES CONTACTED CLINIC/INJECTOR AGAIN REQUESTING INFORMATION REGARDING THIS CLINICAL COMPLAINT. ON 18 FEB 2022, A SALES REPRESENTATIVE INFORMED THE QA DEPARTMENT AT PROLLENIUM MEDICAL TECHNOLOGIES THAT SHE FOLLOWED-UP WITH THE CLINIC REGARDING THIS ADVERSE EVENT MULTIPLE TIMES AS WELL, HOWEVER, AS OF 17 FEB 2022, NO RESPONSE FROM THE INJECTOR/CLINIC HAS BEEN RECEIVED. QA DEPARTMENT AT PROLLENIUM MEDICAL TECHNOLOGIES WILL CONTINUE THE INVESTIGATION.

Additional Manufacturer Narrative

THE CLINICAL COMPLAINT HAS BEEN INVESTIGATED. THE LOT NUMBER HAS BEEN VERIFIED AND HAS BEEN CONFIRMED TO BE RELEASED BY THE COMPANY. IT HAS BEEN CONFIRMED THAT NO CLINICAL COMPLAINT HAS BEEN FOUND FOR THE PARTICULAR LOT NUMBER IN QUESTION. THE BATCH RECORD, QC TEST REPORTS, AND TRAINING OF STAFF WERE ANALYSED AND IT HAS BEEN DETERMINED THAT PRODUCT IS WITHIN REQUIRED SPECIFICATIONS, AND MANUFACTURED ACCORDING TO APPROPRIATE PROCEDURES. PROLLENIUM MEDICAL TECHNOLOGIES' MEDICAL DIRECTOR'S RESPONSE TO THIS ADVERSE EVENT WILL BE PROVIDED TO THE CLINIC ALONG WITH THE LETTER INDICATING APPROVED AREAS FOR INJECTION FOR REVANESSE LIPS+ PRODUCT WHEN REQUESTED INFORMATION FOR CONDUCTING INVESTIGATION IS PROVIDED.

Description of Event or Problem

TREATMENT INFORMATION: BASED ON THE INFORMATION PROVIDED, THE PATIENT GOT INJECTED WITH REVANESSE LIPS+ (WITH LIDOCAINE) IN THE LIPS AREA OF THE PATIENT ON (B)(6) 2022. AMOUNT OF PRODUCT INJECTED WAS 0.1 ML ACCORDING TO THE INITIAL REPORT. PATIENT IS FEMALE; DATE OF BIRTH IS (B)(6) 1977. ADVERSE EVENT INFORMATION: ACCORDING TO THE INITIAL REPORT, THE PATIENT WAS EXPERIENCING ALLERGIC REACTION. RESULTS OF INTERNAL INVESTIGATION: THE CLINICAL COMPLAINT HAS BEEN ADEQUATELY INVESTIGATED. THE LOT NUMBER HAS BEEN VERIFIED AND HAS BEEN CONFIRMED TO BE RELEASED BY THE COMPANY. IT HAS BEEN CONFIRMED THAT NO CLINICAL COMPLAINT HAS BEEN FOUND FOR THE PARTICULAR LOT NUMBER IN QUESTION. THE BATCH RECORD, QC TEST REPORTS, AND TRAINING OF STAFF WERE ANALYSED AND IT HAS BEEN DETERMINED THAT PRODUCT IS WITHIN REQUIRED SPECIFICATIONS, AND MANUFACTURED ACCORDING TO APPROPRIATE PROCEDURES RESULTS OF MEDICAL ASSESSMENT: PROLLENIUM MEDICAL TECHNOLOGIES INC. MEDICAL DIRECTOR OPINION COULD NOT BE CONSULTED AS ADEQUATE INFORMATION WAS NOT PROVIDED DURING FOLLOW UPS WITH CLINICS TO MAKE A SUITABLE MEDICAL ASSESSMENT. PROLLENIUM WILL BE CONCLUDING ITS INVESTIGATIONS AND CLOSING THIS REPORT. INTERNAL REPORT NUMBER: (B)(4).