BEUDAMED
    FDA Adverse Event Injury Summary report: N

    REVANESSE LIPS+ (WITH LIDOCAINE) 1.2 ML

    MDR report key: 19795326 · Received July 22, 2024

    Report

    Report Number
    3004423487-2024-00013
    Event Type
    Injury
    Date Received
    July 22, 2024
    Date of Event
    June 18, 2024
    Report Date
    July 18, 2024
    Manufacturer
    PROLLENIUM MEDICAL TECHNOLOGIES INC.
    Product Code
    LMH
    UDI-DI
    10669808003032
    PMA / PMN Number
    P160042 S014
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    117

    Narratives

    Description of Event or Problem · 0

    ADVERSE EVENT INFORMATION: THE INJECTOR REPORTS TO THAT THE PATIENT WAS INJECTED WITH REVANESSE LIPS+ (WITH LIDOCAINE) 1.2ML,23K091 ON (B)(6) 2024 ON THE LIPS, 1.0ML OF PRODUCT WAS INJECTED. THE PATIENT CAME FOR A FOLLOW UP TWO WEEKS LATER AND COMPLAINED OF HER LIPS FEELING CHAPPED AT THE WET DRY BORDER. THEY ARE TENDER AND IRRITATED AND STILL SLIGHTLY SWOLLEN. THE PATIENT HAS ONLY USED AQUAPHOR ON HER LIPS FOR THE PAST FEW WEEKS. THE PATIENT HAS HAD FILLER PREVIOUSLY, BUT IT'S BEEN ABOUT 1 YEAR AGO.PROLLENIUM MEDICAL TECHNOLOGIES' MEDICAL DIRECTOR'S RESPONSE TO THIS ADVERSE EVENT CAN BE FOUND BELOW: THE FOLLOWING IS A CLINICAL OPINION BASED ON THE LIMITED INFORMATION PROVIDED IN CASE (B)(4). ON (B)(6) 2024 A RN INJECTED 1.0CC OF REVANESSE LIPS + INTO A PATIENT'S LIPS. THE WERE NO CONCERNS OR ADVERSE EVENTS REPORTED AT THE TIME OF INJECTION. NO PAST MEDICAL HISTORY SUCH AS MEDICATIONS, ALLERGIES OR RECENT INFECTIONS WAS PROVIDED. NO BEFORE OR AFTER PHOTOS WERE PROVIDED. TWO WEEKS LATER THE PATIENT CALLED THE INJECTING RN TO COMPLAIN THAT HER LIPS " FELT DRY AND CHAPPED". THE PATIENT HAD BEEN APPLYING AQUAPHOR OINTMENT TO HER LIPS FOR 2 WEEKS. NO MEDICAL EXAM WAS PERFORMED OR PROVIDED BY THE CLINIC. THE PATIENT PROVIDED TWO SELFIES OF HER LIP EVERTED AND STRETCHED. THE PHOTOS SHOWED A FEW NORMAL FORDYCES GLANDS, NO RASH, NO NODULES, AND NO INFLAMMATION. THE LIPS DID APPEAR ROBUSTLY FILLED WHICH IS AN INJECTING TECHNIQUE THAT CREATES AN UNNATURAL ANATOMIC APPEARANCE. MY CLINICAL OPINION IS THAT THERE IS NO EVIDENCE PRESENTED TO SUPPORT AN ADVERSE EVENT IN THIS CASE. IT IS IMPORTANT TO NOTE THAT AQUAPHOR OINTMENT CONTAINS MULTIPLE OILS AND INGREDIENTS THAT CAN CAUSE CONTACT OR ALLERGIC REACTIONS. LANOLIN ALCOHOL IS WELL DOCUMENTED TO CAUSE SKIN REACTIONS. RICINUS SEED OIL (WHICH IS PROCESSED TO MAKE CASTOR OIL AND THE POISON RICIN) CAN CAUSE SKIN REACTIONS. ALSO, CAMOMILE OIL IS FROM THE COMPOSITAE FAMILY OF PLANTS WHICH IS CLOSELY RELATED TO RAGWEED & CHRYSANTHEMUMS. ANY OF THESE INGREDIENTS IN AQUAPHOR CAN CAUSE " DRY & CHAPPED LIPS".

    Description of Event or Problem · 0

    ADVERSE EVENT INFORMATION: THE INJECTOR REPORTS TO THAT THE PATIENT WAS INJECTED WITH REVANESSE LIPS+ (WITH LIDOCAINE) 1.2ML,23K091 ON (B)(6) 2024 ON THE LIPS, 1.0ML OF PRODUCT WAS INJECTED. THE PATIENT CAME FOR A FOLLOW UP TWO WEEKS LATER AND COMPLAINED OF HER LIPS FEELING CHAPPED AT THE WET DRY BORDER. THEY ARE TENDER AND IRRITATED AND STILL SLIGHTLY SWOLLEN. THE PATIENT HAS ONLY USED AQUAPHOR ON HER LIPS FOR THE PAST FEW WEEKS. THE PATIENT HAS HAD FILLER PREVIOUSLY, BUT IT'S BEEN ABOUT 1 YEAR AGO. PROLLENIUM MEDICAL TECHNOLOGIES INC. WAS NOT ABLE TO CONSULT ITS MEDICAL DIRECTOR OWING TO THE LACK OF INFORMATION PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2221370 REVANESSE LIPS+ (WITH LIDOCAINE) 1.2 ML REVANESSE LIPS+ (WITH LIDOCAINE) 1.2 ML LMH PROLLENIUM MEDICAL TECHNOLOGIES INC. PN40149 23K091 10669808003032

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Female Other