BEUDAMED
    FDA Adverse Event Injury Summary report: N

    REVANESSE VERSA+ 1.2 ML

    MDR report key: 21201900 · Received January 21, 2025

    Report

    Report Number
    3004423487-2024-00032
    Event Type
    Injury
    Date Received
    January 21, 2025
    Date of Event
    December 19, 2024
    Report Date
    January 17, 2025
    Manufacturer
    PROLLENIUM MEDICAL TECHNOLOGIES INC.
    Product Code
    LMH
    UDI-DI
    10669808001038
    PMA / PMN Number
    P160042 S004
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    117

    Narratives

    Additional Manufacturer Narrative · 0

    MEDICAL OPINION FROM PROLLENIUM MEDICAL TECHNOLOGIES INC.: ON (B)(6) 2024 A RN INJECTOR INJECTED 1.2 CC OF REVANESSE VERSA + INTO A PATIENTS LIPS. THERE WERE NO CONCERNS OR ADVERSE EVENTS AT THE TIME OF INJECTION. NO TREATMENT PLAN WAS PROVIDED HOWEVER BASED ON THE POST PHOTO IT APPEARS THE TECHNIQUE OF VERTICAL LINEAR STRUT WAS USED. COMPOUNDED TOPICAL ANESTHETIC WITH LIDOCAINE 23%, TETRACAINE 7% IN "PLASTICIZED TOPICAL GEL", WAS APPLIED PRIOR TO INJECTION. "STRATAMED ADVANCED FILM-FORMING WOUND DRESSING" WAS APPLIED TO THE LIPS POST TREATMENT. NO BEFORE PHOTOS OR IMMEDIATE AFTER PHOTOS WERE PROVIDED OR TAKEN OF AREA IN QUESTION. SIX OR MORE+ MONTHS LATER THE PATIENT NOTICED A SMALL CENTRAL AREA OF FULLNESS IN THE INNER CENTRAL EVERTED LIP. THERE WAS NO PAIN, NO NODULES AND NO SIGNS OF INFLAMMATION. MY CLINICAL OPINION IS THAT THIS CASE REPRESENTS SUBOPTIMAL PRODUCT PLACEMENT. THIS IS VERY COMMON WITH VERTICAL STRUTS AS THESE ARE PERFORMED VERY SUPERFICIALLY TO AVOID THE SUPERIOR LABIAL ARTERY AND ARE DONE WITHOUT DIRECT VISUALIZATION. I SEE NO EVIDENCE IN THIS CASE OF A PRODUCT ADVERSE EVENT.

    Description of Event or Problem · 0

    PATIENT RECEIVED THE INJECTION ON (B)(6) 2024. SUPERFICIAL MIGRATION OF FILLER OBSERVED 6+ MONTHS POST TREATMENT WITHIN WET TO DRY BORDER ON UPPER LIP. INTERNAL REPORT NUMBER: (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    669766 REVANESSE VERSA+ 1.2 ML REVANESSE VERSA+ LMH PROLLENIUM MEDICAL TECHNOLOGIES INC. 40083 23D117 10669808001038

    Patients

    Seq Age Sex Outcome Treatment
    1 36 YR Female