BEUDAMED
    FDA Adverse Event Injury Summary report: N

    REVANESSE LIPS+ 1.2 ML

    MDR report key: 14431052 · Received May 18, 2022

    Report

    Report Number
    3004423487-2022-00022
    Event Type
    Injury
    Date Received
    May 18, 2022
    Date of Event
    April 18, 2022
    Report Date
    May 17, 2022
    Manufacturer
    PROLLENIUM MEDICAL TECHNOLOGIES INC.
    Product Code
    LMH
    UDI-DI
    10669808003032
    PMA / PMN Number
    P160042 S014
    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 LIPS+ PRODUCT: "THE FOLLOWING IS A MEDICAL OPINION BASED ON THE INFORMATION AND PICTURES PROVIDED BELOW FROM THE LEGACY HEALTH AND WELLNESS CLINIC; ON (B)(6) 2022 A PATIENT WHO IS A STAFF MEMBER RECEIVED A LIP ENHANCEMENT USING 0.8 MLS OF REVANESSE LIPS+ HA. COMPOUNDED BLT TOPICAL ANESTHETIC WAS USED PRIOR TO INJECTION. APPROXIMATELY 8 WEEKS LATER THE PATIENT NOTICED A BLUE DISCOLOURATION IN THE CENTRAL LOWER LIP. THERE WAS NO PAIN, NO ERYTHEMA, NO NECROSIS AND NO LUMPS OR NODULES. THE PATIENT APPLIED TOPICAL CBD AND ARNICA WITH NO CHANGE TO THE BLUE HUE. AN AFTER PHOTO AND VIDEO WERE PROVIDED. THERE WAS NO PRE PHOTO. THE PHOTOS PROVIDED COUPLED WITH THE ONSET OF DISCOLOURATION IS IN KEEPING WITH A DIAGNOSIS OF A VENOUS LAKE. VENOUS LAKES OCCUR NATURALLY FROM UV EXPOSURE OR TRAUMA (SUCH AS BITING THE LIP) AND USUALLY OCCUR ON THE LOWER LIP. VASCULAR DILATATION WITH CORRESPONDING BLOOD POOLING IS WHY THE BLUE HUE CAN BE INTERMITTENT. UNFORTUNATELY THERE IS NO PRE PHOTO TO DETERMINE IF THIS WAS A PRE EXISTING CONDITION THAT WAS MADE MORE VISIBLE DUE TO THE VOLUMIZATION OF THE LIP. IT MUST THEREFORE BE ASSUMED THAT THE VENOUS LAKE FORMED FROM TRAUMA TO THE VEIN BY THE NEEDLE AT THE TIME OF INJECTION. MY CLINICAL OPINION IS THAT THIS REPRESENTS A TRAUMATIC VENOUS LAKE OF THE LOWER LIP CAUSED BY THE INTRODUCTION OF A NEEDLE INTO THE LIP AND VEIN. I TRUST THIS OPINION WILL BE OF VALUE TO ALL PARTIES CONCERNED."

    Description of Event or Problem · 0

    BASED ON THE INFORMATION PROVIDED, THE PATIENT WAS INJECTED WITH 0.8 ML OF REVANESSE LIPS+ (WITH LIDOCAINE) INTO THE LIPS AREA OF THE PATIENT ON (B)(6) 2022. PATIENT IS (B)(6) FEMALE CAUCASIAN. DOB-(B)(6). ACCORDING TO THE INJECTOR, ROUGHLY 8 WEEKS AFTER THE INITIAL INJECTION, THE PATIENT REPORTS A DARK BLUE HUE OVER PORTIONS OF THE BOTTOM LIP. THERE IS NO PAIN OR SWELLING. CAPILLARY REFILL IS ALSO NORMAL. THE PATIENT COVERED THE AREA IN ARNICA GEL AND CBD GEL AND THERE WAS SIGNIFICANT IMPROVEMENT OVER THE NEXT 2 DAYS. THE BLUE AREA HAS IMPROVED SIGNIFICANTLY, BUT A SMALL AREA DOES REMAIN. PATIENT HAS NOTED THE BLUE HUE APPEAR TWICE SINCE THE INJECTION. HOWEVER IT HAS NEVER BEEN THIS SIGNIFICANT. MEDICATIONS AFTER OR BEFORE THE TREATMENT: ARNICA APPLIED IMMEDIATELY AFTER INJECTIONS; NO PRETREATMENT. CBD APPLIED AT THE PATIENTS HOUSE. TOPICAL BLT WAS USED AS TOPICAL ANAESTHETIC. PREVIOUS DERMAL FILLER TREATMENTS REPORTED: LIP FILLER OVER TWO YEARS AGO AT A DIFFERENT CLINIC. PATIENT HAS SKIN TYPE III. PATIENT HAS BEEN FULLY VACCINATED FOR COVID-19. PATIENT HAS NO PRE-EXISTING RISK FACTORS. NO MEDICAL HISTORY REPORTED. NO MEDICATIONS REPORTED. PATIENT TAKES OTC COLLAGEN SUPPLEMENTS. NO ALLERGIES TO DERMAL FILLER REPORTED. NO ELEVATED FITZPATRICK REPORTED. THE MEDICAL DIRECTOR OF THE CLINIC HAS BEEN NOTIFIED OF THIS ADVERSE EVENT. CURRENT STATUS OF THE PATIENT: SIGNIFICANT IMPROVEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1711105 REVANESSE LIPS+ 1.2 ML REVANESSE LIPS+ LMH PROLLENIUM MEDICAL TECHNOLOGIES INC. 40149 21K057 10669808003032

    Patients

    Seq Age Sex Outcome Treatment
    1 38 YR Female