BEUDAMED
    FDA Adverse Event Injury Summary report: N

    REVANESSE VERSA+ 1.2 ML

    MDR report key: 12857707 · Received November 22, 2021

    Report

    Report Number
    3004423487-2021-00023
    Event Type
    Injury
    Date Received
    November 22, 2021
    Date of Event
    September 22, 2021
    Report Date
    January 13, 2022
    Manufacturer
    PROLLENIUM MEDICAL TECHNOLOGIES INC.
    Product Code
    LMH
    UDI-DI
    10669808001038
    PMA / PMN Number
    P160042 S015
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    117

    Narratives

    Additional Manufacturer Narrative · 0

    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. PROLLENIUM MEDICAL TECHNOLOGIES' MEDICAL DIRECTOR'S RESPONSE TO THIS ADVERSE EVENT WAS PROVIDED TO THE CLINIC ALONG WITH THE LETTER INDICATING APPROVED AREAS FOR INJECTION FOR REVANESSE VERSA+ PRODUCT: "THE FOLLOWING IS A CLINICAL OPINION BASED ON THE INFORMATION PROVIDED BELOW; ON (B)(6), 2021 A 42 Y.O. FEMALE WITH A HISTORY OF MS WAS TREATED WITH 0.8 MLS OF REVANESSEVERSA + IN HER LIPS AND 0.2MLS IN EACH LOWER NLF ( BASED ON HISTORY AND AFTER PHOTOS). THE PATIENT WAS ON OCREVUS A BIOLOGIC THAT WEAKENS THE IMMUNE SYSTEM. THE PATIENT ALSO RECEIVED 40 UNITS OF NEUROMODULATOR JEUVEAU WITH WOULD HAVE BEEN INJECTED INTO THE UPPER 1/3 OF THE FACE, LATERAL AND MEDIAL TO THE AREA OF CONCERN. NO FILLER WAS USED IN OR NEAR THE AREA OF CONCERN BASED ON THE HISTORY PROVIDED. UNFORTUNATELY DESPITE REPEATED REQUESTS NO PRE PHOTOS WERE PROVIDED. THERE WERE NO ISSUES AT THE TIME OF INJECTION AND NO COMPLAINTS RELATED TO THE AREAS OF FILLER INJECTION. APPROXIMATELY ONE WEEK LATER THE PATIENT COMPLAINED OF INFRAORBITAL LOCALIZED SWELLING WHICH CORRESPONDS WITH THE TIME THAT THE JEUVEAU NM WOULD HAVE HAD ITS ONSET OF ACTION. THE LIMITED POST PHOTOS PROVIDED CLEARLY SHOW UNDEREYE FESTOONING WHICH IS A VERY COMMON CONDITION OF THE AGING FACE. FESTOONING IS A CASCADING DRAPING OF EDEMATOUS EXCESS SKIN SEEN INFERIOR TO THE INFRAORBITAL RIM. IT IS A COMMON CONDITION CAUSE BY AGE RELATED SKIN LAXITY IN THE ALREADY THIN SKIN OF THIS AREA. ENVIRONMENTAL INFLAMMATION ( SUN, SMOKING ) COUPLED WITH LOWER EYELID DERMATOCHALASIS AND WEAKENING OF THE THIN OBICULARIS OCCULI MUSCLE ALSO PLAY A ROLE IN THIS CONDITION. THE CONDITION IS EXACERBATED BY INCREASING AGE, FAIR SKIN, SMOKING AND SUN EXPOSURE. THIS PATIENT HAS ALL FOUR OF THESE RISK FACTORS. IN ADDITION THE OBICULARIS OCCULI MUSCLE WAS FURTHER WEAKENED BY THE INJECTION OF NEUROMODULATOR. LIFESTYLE FACTORS SUCH AS EXCESS SALT INTAKE, EXCESS WATER INTAKE ( FORCED HYDRATION) AND ALCOHOL CONSUMPTION WILL ALSO EXAGGERATE THE APPEARANCE OF THIS AGE RELATED CONCERN. MY CLINICAL OPINION IS THAT THIS CASE DOES NOT REPRESENT AN AE RELATED TO HYALURONIC ACID FILLER. IT MAY REPRESENT AN AE RELATED TO THE INJECTION OF JEUVEAU NM AND THEREFORE THE INJECTING NURSE SHOULD REPORT THIS TO THE COMPANY AND FDA. IT MOST LIKELY REPRESENTS A EXACERBATION OF A COMMON PREEXISTING CONDITION WHICH COULD EASILY BE ASSESSED WITH A PRE PHOTO. I TRUST THIS CLINICAL OPINION WILL BE OF VALUE TO ALL PARTIES INVOLVED."

    Additional Manufacturer Narrative · 0

    AFTER MULTIPLE COMMUNICATIONS WITH CLINIC AND PATIENT VIA EMAIL/TELEPHONE, NO INFORMATION REGARDING THIS ADVERSE EVENT HAS BEEN RECEIVED AS OF 22 NOV 2021 BESIDES INITIAL NOTIFICATION INFORMATION. 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 · 0

    BASED ON THE INFORMATION PROVIDED, PATIENT WAS TREATED WITH REVANESSE VERSA+ 1.2 ML ON (B)(6) 2021. AFTER CONTINUOUS COMMUNICATION ATTEMPTS, QA DEPARTMENT HAS RECEIVED INFORMATION REGARDING THIS CLINICAL COMPLAINT ON (B)(6) 2021. REVANESSE VERSA+ INJECTED IN THE LIPS AND NASOLABIAL FOLD AREAS OF THE PATIENT. THE VOLUME INJECTED IS 1.2 ML. 0.8 ML INTO THE LIPS AND 0.4 ML INTO THE NASOLABIAL FOLDS BILATERALLY ALONG WITH 40 IU OF JEUVEAU NEUROTOXIN. PATIENT IS 42 Y.O. (DATE OF BIRTH: (B)(6) 1978) FEMALE. ACCORDING TO THE INJECTOR, THE TREATMENT PLAN WAS: ZYRTEC PRN , SLEEP WITH HOB ELEVATED AND COME IN FOR LYPHATIC MASSAGE PATIENT HAS REFUSED MASSAGE NOT A FIRST TIME DERMAL FILLER TREATMENT. NO ALLERGIES TO DERMAL FILLER TREATMENTS REPORTED. ELEVATED FITZPATRICK SCALE: 2. MEDICATIONS AFTER/BEFORE THE TREATMENT: ANTI-HISTAMINES, ZYRTEC. THERE IS A HISTORY OF M.S. TREATED WITH OCREVUS. , PATIENT HAD HER COVID-19 VACCINE ABOUT A YEAR AGO AND A BOOSTER IN (B)(6) OF 2021. PATIENT IS A 1/2 PPD SMOKER . ALLERGIES TO PCN AND HAS USED HA FILLER PRIOR / 3 YEARS AGO. TOPICAL ANESTHETIC USED: (B)(4). MEDICAL DIRECTOR OF THE CLINIC HAS BEEN INFORMED REGARDING THIS CLINICAL COMPLAINT. STATUS OF THE PATIENT AS OF (B)(6) 2021: PATIENT WAS REFUNDED HER TREATMENT AND INJECTOR HAS NOT HEARD FROM PATIENT SINCE. AS REPORTED BY INJECTOR, DETAILS OF THE ADVERSE REACTION WITH SYMPTOMS: PATIENT APPEARED VERY HAPPY AFTER THE TREATMENT BUT STARTED EXPERIENCING PERI-ORBITAL EDEMA APPROXIMATELY 1 WEEK LATER. IT LASTED FOR GREATER THAN ONE MONTH MOSTLY UNDER THE EYES. PATIENT DID NOT RECEIVE INJECTIONS UNDER THE EYES OR IN THE VICINITY OF THE EYES. PATIENT WAS HAPPY WITH RESULTS AND EVEN RECOMMENDED A FRIEND AND APPARENTLY STARTING EXPERIENCING PERI ORBITAL EDEMA BILATERALLY. ABOUT 1 WEEK LATER MORE SEVERE, BUT PATIENT REPORTS SWELLING WAS PROGRESSIVE FROM DAY OF INJECTION).

    Description of Event or Problem · 0

    BASED ON THE INFORMATION PROVIDED, PATIENT WAS TREATED WITH REVANESSE VERSA+ 1.2 ML ON (B)(6) 2021. PATIENT IS FEMALE AND (B)(6). ON (B)(6) 2021, PATIENT WAS INJECTED IN THE LIPS AND NASOLABIAL FOLDS AREA WITH REVANESSE VERSA+ 1.2 ML. PATIENT CLAIMS OF SWELLING POST-TREATMENT, THEN IT STARTED GETTING WORSE A WEEK LATER AND HAS STAYED BAD UNTIL NOW. ON 22 OCT 2021, QUALITY ASSURANCE DEPARTMENT HAS REACHED OUT TO THE CLINIC THAT PATIENT WAS TREATED AT, VERIFYING AND REQUESTING MORE INFORMATION. THE SAME DAY OF NOTIFICATION. ON 04 NOV 2021, QA DEPARTMENT HAS REACHED OUT TO CLINIC REGARDING REQUESTED INFORMATION. HOWEVER, CLINIC HAS NOT PROVIDED ANY RESPONSE. ON 12 NOV 2021, QA DEPARTMENT HAS REACHED OUT TO CLINIC AGAIN REGARDING REQUESTED INFORMATION. HOWEVER, CLINIC HAS NOT PROVIDED ANY RESPONSE. ON 18 NOV 2021, QA DEPARTMENT HAS REACHED OUT TO CLINIC AGAIN REGARDING REQUESTED INFORMATION. HOWEVER, CLINIC HAS NOT PROVIDED ANY RESPONSE. ON 22 NOV 2021, QA DEPARTMENT HAS REACHED OUT TO CLINIC AGAIN REGARDING REQUESTED INFORMATION. HOWEVER, CLINIC HAS NOT PROVIDED ANY RESPONSE. 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 22 NOV 2021. QA DEPARTMENT WILL CONTINUE THE INVESTIGATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1755814 REVANESSE VERSA+ 1.2 ML REVANESSE VERSA+ LMH PROLLENIUM MEDICAL TECHNOLOGIES INC. 40083 21F110 10669808001038

    Patients

    Seq Age Sex Outcome Treatment
    1 42 YR Female