BEUDAMED
    FDA Adverse Event Injury Summary report: N

    REVANESSE VERSA+ 1.2 ML

    MDR report key: 14788770 · Received June 23, 2022

    Report

    Report Number
    3004423487-2022-00027
    Event Type
    Injury
    Date Received
    June 23, 2022
    Date of Event
    May 18, 2022
    Report Date
    June 23, 2022
    Manufacturer
    PROLLENIUM MEDICAL TECHNOLOGIES INC.
    Product Code
    LMH
    UDI-DI
    10669808001038
    PMA / PMN Number
    P160042 S014
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    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 OTHER CLINICAL COMPLAINTS WERE FOUND ASSOCIATED WITH THIS LOT NUMBER. 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 TO BE 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 CLINICAL INFORMATION PROVIDED BY THE CLINIC. ON (B)(6) 2022 THE PATIENT HAD 1.2 CC OF VERSA + INJECTED INTO THE VERMILLION BORDER OF HER LIPS. THERE WERE NO REPORTED CONCERNS OR ADVERSE EVENTS. THREE TO FOUR MONTHS LATER THE PATIENT WOKE WITH ASYMMETRIC SWELLING OF HER LEFT UPPER LIP ON THE INNER ORAL MUCOSA. THERE WAS NO SWELLING IN ANY FILLER AREAS. THERE IS A HISTORY OF CODEINE ALLERGY. AS WE KNOW THE MOST COMMON REASON FOR LOCALIZED LIP ANGIOEDEMA IS FOODS AND DRUGS. THE EVENT RESOLVED SPONTANEOUSLY WITH NO TREATMENT OR FOLLOW UP ASSESSMENT BY THE CLINIC. MY CLINICAL OPINION BASED ON THE INFORMATION AND PHOTO PROVIDED IS THAT IS A CASE OF ENVIRONMENTAL LOCALIZED ANGIOEDEMA UNRELATED TO HA FILLER. THIS IS NOT A FILLER AE IN MY OPINION. I HOPE THIS CLINICAL OPINION IS OF VALUE TO ALL PARTIES CONCERNED.

    Description of Event or Problem · 0

    BASED ON THE INFORMATION PROVIDED, THE PATIENT WAS INJECTED WITH REVANESSE VERSA+ (WITH LIDOCAINE) IN UNSPECIFIED AREA OF THE PATIENT ON (B)(6) 2022. AMOUNT OF PRODUCT INJECTED WAS "1 TUBE", ACCORDING TO THE INITIAL REPORT. PATIENT IS FEMALE, CAUCASIAN; AGE OF THE PATIENT IS 55 YEARS OLD. ACCORDING TO THE INITIAL REPORT, THE PATIENT WAS EXPERIENCING "STRING" ON THE RIGHT INSIDE LOWER LIP ABOUT A WEEK AND A HALF BEFORE (B)(6) 2022. ACCORDING TO THE PATIENT, THE PATIENT AWOKE WITH A HARD LUMP IN HER UPPER LEFT LIP EITHER ON 18TH OR 19TH, WITHIN AN UNSPECIFIED MONTH. SINCE THEN, THE PATIENT DEVELOPED A SMALL LUMP IN THE LOWER LIP AND THE UPPER LIP THAT ORIGINALLY HAD THE LUMP THAT THE INJECTOR INSTRUCTED TO GENTLY BUT FIRMLY SMOOTH OUT HAS GOTTEN BIGGER. PATIENT STATED THAT IT WAS HARD TO DRINK ANYTHING WITHOUT "LEAKING". PATIENT WAS GIVEN 20 MG OF PREDNISONE P.O. AFTER INJECTION. AS REPORTED, THE PATIENT HAS BEEN FULLY VACCINATED AND BOOSTED. RETIRED TEACHER. PATIENT WAS IN A CAR ACCIDENT AT AGE 8 WITH LOTS OF FACIAL SCARS, INCLUDING ACROSS THE LEFT UPPER LIP. THE PATIENT DOES NOT HAVE PRE-EXISTING RISK FACTORS. ELEVATED FITZPATRICK SCALE OF 2 REPORTED. NO TOPICAL ANAESTHETIC USED DURING THE PROCEDURE, COLD PEN. NO ALLERGIES TO DERMAL FILLERS REPORTED. THE PATIENT IS ALLERGIC TO CODEINE. PATIENT IS NOT A FIRST TIME DERMAL FILLER TREATMENT AND HAS HAD A DERMAL FILLER TREATMENT THREE YEARS AGO INTO NASO LABIAL FOLDS WITH NO PROBLEM. THE MEDICAL DIRECTOR OF THE CLINIC HAS BEEN INFORMED OF THIS ADVERSE EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    307843 REVANESSE VERSA+ 1.2 ML REVANESSE VERSA+ LMH PROLLENIUM MEDICAL TECHNOLOGIES INC. 40083 21G067 10669808001038

    Patients

    Seq Age Sex Outcome Treatment
    1 55 YR Female