BEUDAMED
    FDA Adverse Event Injury Summary report: N

    REVANESSE VERSA+ 1.2 ML

    MDR report key: 11987409 · Received June 11, 2021

    Report

    Report Number
    3004423487-2021-00009
    Event Type
    Injury
    Date Received
    June 11, 2021
    Date of Event
    May 12, 2021
    Report Date
    June 11, 2021
    Manufacturer
    PROLLENIUM MEDICAL TECHNOLOGIES INC.
    Product Code
    LMH
    UDI-DI
    10669808001038
    PMA / PMN Number
    P160042
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    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 PREVIOUS CLINICAL COMPLAINTS HAVE 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. THIS COMPLAINT IS CONSIDERED AS OFF LABEL USE AND THE CLINIC HAVE BEEN INFORMED BY PROLLENIUM MEDICAL TECHNOLOGIES THAT INJECTIONS INTO UNAPPROVED AREAS SUCH AS THE LIPS, LOWER EYELID, TEAR TROUGHS AND MEDIAL CHEEKS ARE TO BE AVOIDED AS STATED IN THE REVANESSE® VERSATM+ DIRECTIONS FOR USE (DFU) AVAILABLE AT WWW.HTTP://REVANESSEUSADFU.COM/. PROLLENIUM MEDICAL TECHNOLOGIES' MEDICAL DIRECTOR'S RESPONSE TO THIS ADVERSE EVENT WAS PROVIDED TO THE CLINIC. THE RESPONSE FROM MEDICAL DIRECTOR IS AS FOLLOWS: "THE FOLLOWING IS A MEDICAL OPINION BASED ON THE INFORMATION PROVIDED IN THE AE REPORT BELOW; THE AFTER PHOTOS PROVIDED BY THE CLINIC SHOW INJECTION OF THE UPPER VERMILLION BORDER WITH NO SIGN OF CENTRAL BODY FILLING. THE HISTORY INDICATES ONLY A HALF SYRINGE OF PRODUCT WAS USED ACROSS BOTH LIPS. THERE IS NO MENTION OF TOUCH UP FILLER PLACED IN THE PATIENTS CENTRAL UPPER LIP. THE AREA OF CONCERN PHOTOS PROVIDED BY THE PATIENT SHOWS NO INFLAMMATION, REDNESS, INDURATION OR EDEMA. THERE APPEARS TO BE A VERY DEFINED AREA OF ASYMMETRY CENTRALLY ON THE UPPER LIP. THE AP PICTURES SHOW WHAT COULD BE A SMALL MACERATED SPOT ASSOCIATED WITH THE ASYMMETRY. THIS WOULD BE CONSISTENT WITH THE PATIENT CHEWING ON THIS AREA OR A HEALING COLD SORE. THERE IS NO DIAGNOSIS FROM THE URGENT CARE CLINIC NOR WAS THE PATIENT CLINICALLY ASSESSED BY THE CLINIC STAFF OR THEIR MEDICAL DIRECTOR. I SEE NO EVIDENCE OF AN AE RELATED TO PRODUCT INJECTED INTO THE LIP. WHEN THE CLINIC PERFORMS AN ASSESSMENT OF THE PATIENTS CONCERN, THEY MAY HAVE MORE CLINICAL INFORMATION TO PROVIDE. I TRUST THIS MEDICAL OPINION IS OF VALUE TO ALL PARTIES CONCERNED."

    Description of Event or Problem · 1

    BASED ON THE INFORMATION PROVIDED, ON (B)(6) 2021, PATIENT - FEMALE (B)(6). FIRST TIME LIP FILLER TREATMENT. PATIENT HAS BEEN INJECTED WITH 0.6 CC OF REVANESSE VERSA+ INTO LIPS. ON (B)(6) 2021, TWO WEEKS LATER, 0.2 CC WAS INJECTED INTO RIGHT UPPER LIP CORNER AND BOTTOM LIP BODY DURING SECOND TREATMENT. ON 12 MAY 2021, PATIENT TOOK AE PHOTOS AT THE CLINIC WITH NO FURTHER TREATMENT. ON (B)(6) 2021, PATIENT CONTACTED QUALITY ASSURANCE DEPARTMENT VIA PHONE AND HAVE COMPLAINED ABOUT SYMPTOMS: SWELLING EACH MORNING, LUMP CENTER, UPPER LIP, UNEVEN. PATIENT STATED TO STAFF, (B)(6) 2021, THAT "EVERYTHING WAS OK" AND SHE WAS BEING SEEN AT AN URGENT CARE BECAUSE SWELLING HAD NOT FULLY RESOLVED. PATIENT WAS NOT GIVEN ONE OF THE FOLLOWING: ARTHRITIS; COLD COMPRESSES; HYALURONIDASE; ANTI-INFLAMMATORY (IE. ADVIL); PREDNISONE; ZITHROMAX; KEFLEX; OTHER ANTIBIOTIC. PATIENT DENIED RECEIVING COVID VACCINE WITHIN 2 WEEKS PRIOR OR AFTER BOTH INITIAL TREATMENT AND WITH TOUCH-UP. TOPICAL ANESTHETIC USED: C-LIDO/TETRA 23/77% LPD PATIENT DID NOT HAVE PRE-EXISTING RISK FACTORS. NO MEDICATIONS BEFORE TREATMENT. NO ALLERGIES REPORTED. ON (B)(6) 2021, PATIENT CONTACTED QUALITY ASSURANCE DEPARTMENT WITH A FOLLOW-UP CALL. QA DEPARTMENT INFORMED PATIENT THEN RESULTS OF INTERNAL INVESTIGATION (BATCH RECORDS, QC TESTS RESULTS) AND PROLLENIUM MEDICAL TECHNOLOGIES' MEDICAL DIRECTOR'S EXPERTISE. PATIENT INFORMED QA DEPARTMENT ASSOCIATE THAT SHE WILL FURTHER CONTACT LEGAL AUTHORITIES. DETAILED TIMELINE OF EVENTS AS REPORTED BY INJECTOR: (B)(6) 2021: PATIENT SEEN FOR DERMAL FILLER TREATMENT TO LIPS WITH 1/2 SYRINGE OF VERSA (0.6CC) TO UPPER AND LOWER LIPS. PATIENT DENIED ANY SIGNIFICANT MEDICAL HISTORY OR HISTORY OF COVID VACCINE OR BACTERIAL/VIRAL INFECTION IN THE LAST 2 WEEKS PRIOR TO INJECTIONS. DENIED HISTORY OF HERPES SIMPLEX. CONSENTS SIGNED. TOPICAL NUMBING USED PRIOR TO TREATMENT. PATIENT PREPPED WITH CHLORAPREP SINGLE SWABSTICK ANTISEPTIC (2% CHLORHEXIDINE WITH 70% ISOPROPYL ALCOHOL, PRIOR TO ALL INJECTIONS. PATIENT TOLERATED TREATMENT WELL. NO COMPLICATIONS. POST-CARE INSTRUCTIONS REVIEWED AND PATIENT VERBALIZED UNDERSTANDING. ADVISED PATIENT TO RETURN IN 2-4 WEEKS FOR FIRST-TIME FILLER PATIENT TOUCH-UP, IF NEEDED, FOR NATURALLY SHAPED M-LIPS. ON (B)(6) 2021: PATIENT RETURNED FOR TOUCH-UP TO LIPS. PATIENT STATES SHE'S VERY PLEASED WITH OVERALL RESULTS BUT WOULD LIKE SLIGHTLY MORE VOLUME. 0.2CC OF VERSA PLUS ADDED TO LIP CORNER AT THE RIGHT UPPER LIP FOR M-SHAPED LIPS AND TO THE BOTTOM LIP BODY. LIPS SMOOTH WITHOUT SWELLING, NODULES, OR GRANULOMAS. LIP COLOR AND CAPILLARY REFILL WITHIN NORMAL LIMITS. POST-CARE INSTRUCTIONS REVIEWED AND PATIENT VERBALIZED UNDERSTANDING. AQUAPHOR OINTMENT APPLIED POST-TREATMENT AND PATIENT ADVISED TO AVOID APPLYING LIPSTICK OR MAKE-UP TO LIPS FOR THE REST OF THE DAY. ON (B)(6) 2021: TELEPHONE ENCOUNTER: PATIENT CALLED STATING SHE WAS CONCERNED ABOUT SWELLING AT UPPER LIP (DEVELOPED 5 WKS 2 DAYS FROM TOUCH-UP AND 7 WEEKS AND 2 DAYS POST-INITIAL TREATMENT). STAFF REQUESTED A PHOTO FROM PATIENT WHO SENT PHOTO LATER IN THE DAY. PHOTO REVIEWED BY NP MEDICAL STAFF AT CLINIC WHICH SHOWED NO CLINICAL SIGNIFICANCE FOR EMERGENT CARE . CLINIC STAFF ATTEMPTED TO BOOK F/U APPOINTMENT FOR PATIENT WHO REFUSED THE DATE AND BOOKED APPOINTMENT FOR FOLLOWING WEEK AT HER CONVENIENCE, MONDAY (B)(6). ON (B)(6) 2021: FOLLOW-UP CALL BY STAFF AT CLINIC. PATIENT STATED "EVERYTHING IS NO OK" BUT WAS IN URGENT CARE BECAUSE HER SWELLING HAS NOT COMPLETELY RESOLVED. PATIENT UNABLE TO SPEAK AT THE TIME BUT STATED SHE APPRECIATED THE CALL-BACK. ON (B)(6) 2021: INFORMED BY SALES REP THAT PATIENT CALLED IN AND REPORTED AN ADVERSE REACTION ON (B)(6), PRIOR TO BEING ASSED OR SEEN BY MEDICAL STAFF. ON (B)(6) 2021: ATTEMPTED TO REACH PATIENT BY PHONE AND NO ANSWER. ON (B)(6) 2021: CALLED PATIENT X2 AND LEFT VOICEMAIL TO CALL THE OFFICE BACK TO FOLLOW-UP AND CONFIRM APPOINTMENT FOR MONDAY. NO RETURN CALLS. PATIENT DID CONFIRM FOLLOW-UP APPOINTMENT WITH FROM DESK FOR MONDAY. ON (B)(6) 2021: PATIENT DID NOT SHOW FOR HER SCHEDULED APPOINTMENT. PATIENT CALLED AND NO ANSWER. UNABLE TO REACH PATIENT FOR REFERRALS OR TO FOLLOW-UP.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    877501 REVANESSE VERSA+ 1.2 ML REVANESSE VERSA+ LMH PROLLENIUM MEDICAL TECHNOLOGIES INC. 40083 21B092 10669808001038

    Patients

    Seq Age Sex Outcome Treatment
    1