BEUDAMED
    FDA Adverse Event Injury Summary report: N

    REVANESSE VERSA+ (WITH LIDOCAINE)

    MDR report key: 23533999 · Received November 12, 2025

    Report

    Report Number
    3004423487-2025-00022
    Event Type
    Injury
    Date Received
    November 12, 2025
    Date of Event
    October 9, 2025
    Report Date
    November 12, 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
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    PATIENT RECEIVED REVANESSE VERSA + (W/ LIDOCAINE) (LOT 241123) IN THE NASOLABIAL FOLDS AND ORAL COMMISSURES VIA MICROCANNULA ON (B)(6) 2025. WAS FINE UP UNTIL EARLY (B)(6) 2025; SHE NOTICED SUDDEN ONSET OF PALPABLE NODULE DEVELOPMENT ON THE AREAS TREATED. THE NODULES ARE PALPABLE, NON-TENDER, AND NON-ERYTHEMATOUS. PATIENT WAS OFFERED TO RESOLVE PRODUCT BUT WANTED TO HOLD OFF SINCE SHE DOES LIKE THE RESULTS NOT JUST THE PALPABLE NODULES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1932367 REVANESSE VERSA+ (WITH LIDOCAINE) Implant, dermal, for aesthetic use LMH PROLLENIUM MEDICAL TECHNOLOGIES INC. PN40083 24I123 10669808001038

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR Female Other