REVANESSE LIPS+ 1.2 ML

Description of Event or Problem

BASED ON THE INFORMATION PROVIDED, PATIENT HAS REPORTED COMPLAINT ON (B)(6) 2021. PATIENT STATED THAT TWO WEEKS PRIOR SHE WAS TREATED WITH EITHER REVANESSE VERSA+ OR REVANESSE LIPS+. PATIENT STATED TO BE INJECTED WITH 3 SYRINGES INTO TEMPLES, JAWLINE, LIPS. PATIENT WAS EXTREMELY DISSATISFIED WITH THE COMPLICATIONS AND PROVIDER (IN)EXPERTISE. PATIENT STATED TO BE LUMPY, PAINED, BRUISED, ASYMMETRICAL AND HAVING POPPING SENSATIONS AND CONSTANT HEADACHES. PATIENT HAS FOLLOWED UP WITH THE OFFICE ROUTINELY PROVIDING PHOTOS AND REQUESTS FOR CORRECTION - AND SIMPLY PUT, HAS BEEN MET WITH DISMISSIVE, UNSATISFACTORY, CONDESCENDING RESPONSES CITING "STANDARD CARE FOR NON-EMERGENCY" PROTOCOL. ON (B)(6) 2021, QUALITY ASSURANCE DEPARTMENT HAS REACHED OUT TO THE CLINIC THAT PATIENT WAS TREATED AT, VERIFYING AND REQUESTING MORE INFORMATION. THE SAME DAY, CLINIC REPRESENTATIVE ACKNOWLEDGED THE REQUEST. THE INFORMATION REGARDING THIS ADVERSE EVENT WAS PROMISED TO BE PROVIDED IF/WHEN HIPAA CONSENT SIGNED BY THE CLIENT TO RELEASE THIS INFORMATION WILL BE OBTAINED. ON (B)(6) 2021, CLINIC REPRESENTATIVE HAS INFORMED QA DEPARTMENT THAT THE PATIENT HAS NOT AUTHORIZED PROLLENIUM TO HAVE ACCESS TO THEIR PHI. THEIR LATEST CONVERSATION ENDED WITH THE PATIENT STATING SHE WOULD BE "ESCALATING THE PROCESS WITH PROLLENIUM". CLINIC WAS NOT ABLE TO PROVIDE ANY FURTHER INFORMATION. ON (B)(6) 2021, QA DEPARTMENT HAS CONDUCTED A MEETING WITH THE PATIENT VIA TELEPHONE AS PER PATIENT'S REQUEST. PATIENT INFORMED QA DEPARTMENT TO VERBALLY GIVE PERMISSION FOR INFORMATION RELEASE. ON (B)(6) 2021, QA DEPARTMENT HAS REACHED OUT TO PATIENT REGARDING HER CURRENT STATE AND IF THE SYMPTOMS REPORTED EARLIER HAVE BEEN RESOLVED. HOWEVER, PATIENT HAS NOT PROVIDED ANY INFORMATION. AFTER MULTIPLE COMMUNICATIONS WITH CLINIC VIA EMAIL, CLINIC AND INJECTOR WERE NOT RESPONSIVE AND HAVE NOT PROVIDED ANY INFORMATION REGARDING THIS ADVERSE EVENT AS OF 12 NOV 2021.

Additional Manufacturer Narrative

AFTER MULTIPLE COMMUNICATIONS WITH CLINIC AND PATIENT VIA EMAIL/TELEPHONE, NO INFORMATION REGARDING THIS ADVERSE EVENT HAS BEEN RECEIVED AS OF 12 NOV 2021. QA DEPARTMENT WILL CONTINUE THE INVESTIGATION. PROLLENIUM MEDICAL TECHNOLOGIES' MEDICAL DIRECTOR'S RESPONSE TO THIS ADVERSE EVENT WILL BE PROVIDED TO THE CLINIC ONCE REQUESTED INFORMATION WILL BE RECEIVED.

Additional Manufacturer Narrative

AFTER MULTIPLE COMMUNICATIONS WITH CLINIC AND PATIENT VIA EMAIL/TELEPHONE, NO INFORMATION REGARDING THIS ADVERSE EVENT HAS BEEN RECEIVED AS OF 12 NOV 2021. QA DEPARTMENT WILL CONTINUE THE INVESTIGATION. PROLLENIUM MEDICAL TECHNOLOGIES' MEDICAL DIRECTOR'S RESPONSE TO THIS ADVERSE EVENT WILL BE PROVIDED TO THE CLINIC ONCE REQUESTED INFORMATION WILL BE RECEIVED.

Description of Event or Problem

BASED ON THE INFORMATION PROVIDED, PATIENT HAS REPORTED COMPLAINT ON (B)(6) 2021. PATIENT STATED THAT TWO WEEKS PRIOR SHE WAS TREATED WITH EITHER REVANESSE VERSA+ OR REVANESSE LIPS+. PATIENT STATED TO BE INJECTED WITH 3 SYRINGES INTO TEMPLES, JAWLINE, LIPS. PATIENT WAS EXTREMELY DISSATISFIED WITH THE COMPLICATIONS AND PROVIDER (IN)EXPERTISE. PATIENT STATED TO BE LUMPY, PAINED, BRUISED, ASYMMETRICAL AND HAVING POPPING SENSATIONS AND CONSTANT HEADACHES. PATIENT HAS FOLLOWED UP WITH THE OFFICE ROUTINELY PROVIDING PHOTOS AND REQUESTS FOR CORRECTION - AND SIMPLY PUT, HAS BEEN MET WITH DISMISSIVE, UNSATISFACTORY, CONDESCENDING RESPONSES CITING "STANDARD CARE FOR NON-EMERGENCY" PROTOCOL. ON 15 OCT 2021, QUALITY ASSURANCE DEPARTMENT HAS REACHED OUT TO THE CLINIC THAT PATIENT WAS TREATED AT, VERIFYING AND REQUESTING MORE INFORMATION. THE SAME DAY, CLINIC REPRESENTATIVE ACKNOWLEDGED THE REQUEST. THE INFORMATION REGARDING THIS ADVERSE EVENT WAS PROMISED TO BE PROVIDED IF/WHEN HIPAA CONSENT SIGNED BY THE CLIENT TO RELEASE THIS INFORMATION WILL BE OBTAINED. ON 26 OCT 2021, CLINIC REPRESENTATIVE HAS INFORMED QA DEPARTMENT THAT THE PATIENT HAS NOT AUTHORIZED PROLLENIUM TO HAVE ACCESS TO THEIR PHI. THEIR LATEST CONVERSATION ENDED WITH THE PATIENT STATING SHE WOULD BE "ESCALATING THE PROCESS WITH PROLLENIUM". CLINIC WAS NOT ABLE TO PROVIDE ANY FURTHER INFORMATION. ON 02 NOV 2021, QA DEPARTMENT HAS CONDUCTED A MEETING WITH THE PATIENT VIA TELEPHONE AS PER PATIENT'S REQUEST. PATIENT INFORMED QA DEPARTMENT TO VERBALLY GIVE PERMISSION FOR INFORMATION RELEASE. ON 10 NOV 2021, QA DEPARTMENT HAS REACHED OUT TO PATIENT REGARDING HER CURRENT STATE AND IF THE SYMPTOMS REPORTED EARLIER HAVE BEEN RESOLVED. HOWEVER, PATIENT HAS NOT PROVIDED ANY INFORMATION. AFTER MULTIPLE COMMUNICATIONS WITH CLINIC VIA EMAIL, CLINIC AND INJECTOR WERE NOT RESPONSIVE AND HAVE NOT PROVIDED ANY INFORMATION REGARDING THIS ADVERSE EVENT AS OF 12 NOV 2021.

Additional Manufacturer Narrative

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 OTHER 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 WAS PROVIDED TO THE CLINIC AND TO THE PATIENT ALONG WITH THE LETTER STATING APPROVED INDICATION FOR THE REVANESSE LIPS+ PRODUCT LINE.

Description of Event or Problem

BASED ON THE INFORMATION PROVIDED FROM THE PATIENT, ON (B)(6), 2021 - DATE OF TREATMENT WITH REVANESSE LIPS+ INJECTED. AFTER MULTIPLE COMMUNICATIONS WITH CLINIC VIA EMAIL OVER FEW MONTHS, CLINIC AND INJECTOR HAVE PROVIDED INFORMATION REGARDING THIS ADVERSE EVENT AS OF (B)(6) 2021. AS REPORTED BY INJECTOR, THE VOLUME INJECTED IS 0.6 ML. PATIENT IS WHITE, FEMALE, 40 Y.O. NOT A FIRST DERMAL FILLER TREATMENT. ACCORDING TO THE INJECTOR, PATIENT HAD NO PRE-EXISTING RISK FACTORS. ACCORDING TO THE INJECTOR, PATIENT TAKES ADDERALL, MULTIVITAMIN AND AMBIEN PRESCRIPTIONS. NO ALLERGIES TO DERMAL FILLER TREATMENTS REPORTED. NO ELEVATED FITZPATRICK SCALE REPORTED. NO MEDICATIONS AFTER/BEFORE THE TREATMENT REPORTED. VACCINATION STATUS FROM COVID-19 HAS NOT BEEN PROVIDED. TOPICAL ANESTHETIC USED: BENZOCAINE/LIDOCAINE/TETRACAINE MEDICAL DIRECTORS OF THE CLINIC AND PROLLENIUM MEDICAL TECHNOLOGIES HAVE BEEN INFORMED REGARDING THIS CLINICAL COMPLAINT. PHOTOS OF THE PATIENT HAS NOT BEEN PROVIDED, HOWEVER WERE REQUESTED MULTIPLE TIMES. PATIENT HAS BEEN GIVEN ONE OF THE FOLLOWING: COLD COMPRESSES; HYALURONIDASE; ANTI-INFLAMMATORY (IE. ADVIL); PREDNISONE; ZITHROMAX; KEFLEX. HOWEVER, WHICH ONE LISTED HAS NOT BEEN SPECIFIED. AS REPORTED BY INJECTOR, PATIENT COMPLAINS OF UNWANTED REACTION, NOT ADVERSE. CLIENT STATES MULTIPLE COMPLAINTS ABOUT PROBLEM AREAS BEING WORSENED AND BROW BEING HEAVY. CLIENT SEEN IN OFFICE ON (B)(6) 2021, CONTINUES TO STATE THINGS ARE WORSENED, PICTURES TAKEN AND COMPARED, WRITER SHOWS CLIENT MARKED IMPROVEMENT IN OVERALL CONTOUR OF FACE. CLIENT STATES HER "FOREHEAD IS NOW CONSTRICTED, JOWLS AND LINES NEAR MOUTH (NOT INJECTED) ARE WORSENED AND A NEW ONE HAS APPEARED, LEFT EYE BROW DROPPED". CLIENT WAS REMINDED THAT INJECTOR DID NOT INJECT TOX INTO FRONTALIS AS PATIENT STATED THE PREVIOUS INJECTOR IN (B)(6) HAD RUINED HER BROW ARCH. CURRENT STATUS OF THE PATIENT: UNHAPPY WITH RESULTS