BEUDAMED
    FDA Adverse Event Injury Summary report: N

    REVANESSE LIPS+ (WITH LIDOCAINE)

    MDR report key: 22006372 · Received May 12, 2025

    Report

    Report Number
    3004423487-2025-00009
    Event Type
    Injury
    Date Received
    May 12, 2025
    Date of Event
    April 11, 2025
    Report Date
    May 6, 2025
    Manufacturer
    PROLLENIUM MEDICAL TECHNOLOGIES INC
    Product Code
    LMH
    UDI-DI
    10669808003032
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    501

    Narratives

    Additional Manufacturer Narrative · 0

    MEDICAL OPINION FROM PROLLENIUM MEDICAL TECHNOLOGIES INC.: ON (B)(6) 2025 A PATIENT RECEIVED LESS THAN 0.4 CC OF REVANESSE LIPS INTO HER UPPER LIP. PRIOR TO INJECTION THE INJECTING RN APPLIED COMPOUNDED HIGH CONCENTRATION TOPICAL ANESTHETIC BLT (BENZOCAINE, LIDOCAINE, TETRACAINE) TO THE PATIENT'S UPPER AND POWER LIPS. WITHIN 5 MIN OF INJECTING THE UPPER LIP THE PATIENTS BOTH LIPS SWELLED IN AN ALLERGIC NATURE. THE PATIENT WAS GIVEN ONE BENADRYL 50 MG TABLET AND THE SWELLING SUBSIDED. THE SMALL AMOUNT OF HA WAS NOT DISSOLVED. THE SWELLING DID NOT REOCCUR. "MY CLINICAL OPINION IS THAT IS A COMMONLY SEEN ALLERGIC REACTION CAUSED BY HIGH CONCENTRATION OF TOPICAL ANESTHETIC APPLIED TO THE THIN EPITHELIUM AND MUCOSA OF THE LIPS. BENZOCAINE IS THE MOST ALLERGENIC OF ALL TOPICAL ANESTHETICS. I SEE NO EVIDENCE OF THIS BEING AN ADVERSE EVENT CAUSED BY HA FILLER AS THE FILLER WAS NOT DISSOLVED AND THE ALLERGIC SWELLING DID NOT RETURN."

    Description of Event or Problem · 0

    PATIENT INFORMATION: THE PATIENT IS A 40-YEAR-OLD FEMALE WITH HSV TYPE I WITH LAST OUTBREAK 1 YEAR AGO, NO HISTORY OF INJECTIONS OR ALLERGIES. ALSO DOES NOT HAVE AUTO IMMUNE CONDITIONS. ADVERSE EVENT INFORMATION: THE CLINIC REPORTED ON (B)(6) 2025 THAT PATIENT WHO WAS INJECTED ON (B)(6) 2025 WITH 4 ML OF REVANESSE LIPS+ WITH LIDOCAINE SHOWED ANGIOEDEMA 5-10 MINUTES POST STARTING INJECTION. HOWEVER, THE CLINIC MANAGER REPORTED TO PROLLENIUM MEDICAL THAT THE PATIENT IS DOING FINE NOW. FOLLOW-UP COMMUNICATIONS WITH CLINIC: AFTER RECEIVING THE REPORT ON 16 APR 2025 BY PROLLENIUM, THEY REACHED OUT TO THE CLINIC TO OBTAIN MORE INFORMATION TO CONDUCT A THROUGH INVESTIGATION. RESULTS OF MEDICAL ASSESSMENT: ON (B)(6) 2025 A PATIENT RECEIVED LESS THAN 0.4 CC OF REVANESSE LIPS INTO HER UPPER LIP. PRIOR TO INJECTION THE INJECTING RN APPLIED COMPOUNDED HIGH CONCENTRATION TOPICAL ANESTHETIC BLT (BENZOCAINE, LIDOCAINE, TETRACAINE) TO THE PATIENT'S UPPER AND POWER LIPS. WITHIN 5 MIN OF INJECTING THE UPPER LIP THE PATIENTS BOTH LIPS SWELLED IN AN ALLERGIC NATURE. THE PATIENT WAS GIVEN ONE BENADRYL 50 MG TABLET AND THE SWELLING SUBSIDED. THE SMALL AMOUNT OF HA WAS NOT DISSOLVED. THE SWELLING DID NOT REOCCUR. "MY CLINICAL OPINION IS THAT IS A COMMONLY SEEN ALLERGIC REACTION CAUSED BY HIGH CONCENTRATION OF TOPICAL ANESTHETIC APPLIED TO THE THIN EPITHELIUM AND MUCOSA OF THE LIPS. BENZOCAINE IS THE MOST ALLERGENIC OF ALL TOPICAL ANESTHETICS. I SEE NO EVIDENCE OF THIS BEING AN ADVERSE EVENT CAUSED BY HA FILLER AS THE FILLER WAS NOT DISSOLVED AND THE ALLERGIC SWELLING DID NOT RETURN."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    392916 REVANESSE LIPS+ (WITH LIDOCAINE) REVANESSE LIPS+ (WITH LIDOCAINE) LMH PROLLENIUM MEDICAL TECHNOLOGIES INC PN40149 24E135 10669808003032

    Patients

    Seq Age Sex Outcome Treatment
    1 40 YR Female Required Intervention