BEUDAMED
    FDA Adverse Event Injury Summary report: N

    REVANESSE VERSA+ 1.2 ML

    MDR report key: 15304942 · Received August 26, 2022

    Report

    Report Number
    3004423487-2022-00042
    Event Type
    Injury
    Date Received
    August 26, 2022
    Date of Event
    July 23, 2022
    Report Date
    August 25, 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: "THE FOLLOWING IS A CLINICAL OPINION BASED ON THE INFORMATION PROVIDED BY THE CLINIC. NO PHOTOGRAPHS WERE SHARED. ON (B)(6) ,2022, A PATIENT RECEIVED 1.2 CCS OF REVANESSE VERSA+ IN HER NLFS. NO OTHER AREAS WERE INJECTED. THERE WERE NO CONCERNS OR COMPLICATION. NO MEDICAL HISTORY WAS PROVIDED. MEDICATIONS AND ALLERGIC HISTORY WERE NOT PROVIDED. ON (B)(6), 2022 THE PATIENT STARTED MELOXICAM DUE TO AN "ANKLE SPRAIN ". WITHIN A FEW DAYS THE PATIENT PRESENTED TO AN URGENT CARE CLINIC WITH "SWELLING" IN HER LEFT AXILLA AND RIGHT LATERAL FACE. THERE WAS NO HISTORY OF SWELLING IN EITHER NLF. SHE WAS GIVEN A DIAGNOSIS OF "INFLAMMATION" NYD. IT IS WORTH NOTING THAT FACIAL SWELLING IS IN THE MOST COMMON SIDE EFFECTS OF MELOXICAM. MEDROL DOSE PAC WAS STARTED, AND THE SWELLING RESOLVED. MY CLINICAL OPINION IS THAT THIS CASE REPRESENTS A REACTION TO MELOXICAM AND DOES NOT REPRESENT AN ADVERSE REACTION TO HA FILLER. I TRUST 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 THE BOTH NASOLABIAL FOLD AREA OF THE PATIENT ON (B)(6) 2022. AMOUNT OF PRODUCT INJECTED WAS 1.2 ML, ACCORDING TO THE INITIAL REPORT. PATIENT IS FEMALE; AGE OF THE PATIENT IS 48 YEARS OLD. DATE OF BIRTH IS (B)(6). ACCORDING TO THE INITIAL REPORT, THE PATIENT TOLERATED PROCEDURE WELL WITHOUT COMPLICATION. ON (B)(6) 2022, A PATIENT REPORTED RIGHT FACE SWELLING. PATIENT ALSO REPORTED SWELLING IN HER LEFT UNDERARM. PATIENT DID NOT FEEL ITCHY. PATIENT WENT TO URGENT CARE AND WAS TOLD IT WAS AN INFLAMMATORY REACTION. THERE IS NO SIGN OF INFECTION. PATIENT IS CURRENTLY ON MEDROL DOSE PACK. IT IS UNKNOWN WHETHER THE PATIENT HAS ANY PRE-EXISTING RISK FACTORS. ACCORDING TO THE INITIAL REPORT. THE PATIENT HAS RECEIVED THE LAST COVID VACCINE IN (B)(6) 2021. PATIENT WAS GIVEN A MEDROL DOSE PACK AND DOXYCYCLINE FROM URGENT CARE. AS PER REPORT, PATIENT TOOK 2 DAYS OF MELOXICAM ON (B)(6) 2022 AND (B)(6) 2022. ELEVATED FITZPATRICK SCALE OF TYPE IV REPORTED. NO TOPICAL ANAESTHETIC WAS USED DURING THE PROCEDURE. NO MEDICATIONS GIVEN AFTER OR BEFORE THE TREATMENT. NO ALLERGIES TO DERMAL FILLERS REPORTED. PATIENT IS A FIRST TIME DERMAL FILLER TREATMENT. CURRENT STATUS OF THE PATIENT: PATIENT FEELS A LITTLE BETTER FOR THE FIRST TIME ON (B)(6) 2022. THE MEDICAL DIRECTOR OF THE CLINIC HAS BEEN INFORMED OF THIS ADVERSE EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1773250 REVANESSE VERSA+ 1.2 ML REVANESSE VERSA+ LMH PROLLENIUM MEDICAL TECHNOLOGIES INC. 40083 21I106 10669808001038

    Patients

    Seq Age Sex Outcome Treatment
    1 48 YR Female