BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RHA 3-1 SYRINGE

    MDR report key: 21255744 · Received January 28, 2025

    Report

    Report Number
    MW5165343
    Event Type
    Injury
    Date Received
    January 28, 2025
    Date of Event
    December 24, 2024
    Report Date
    January 24, 2025
    Manufacturer
    REVANCE THERAPEUTICS, INC.
    Product Code
    LMH
    Adverse Event
    Yes
    Report Source
    Voluntary report
    Reporter Location
    IL, US
    Reporter Occupation
    PATIENT
    Health Professional
    *

    Narratives

    Description of Event or Problem · 0

    INJECTED WITH 15 UNITS OF BOTOX COSMETIC ON (B)(6) 2024. LOT #C9068C3F, EXP 11/2026. INJECTED WITH HYALURONIC ACID COSMETIC FILLER ON (B)(6) 2024. RHA 3-1 SYRINGE, BATH (10)2348R3L0, EXP 11/17/2026. ON (B)(6) 2024, PRESENTED TO ER WITH SYMPTOMS CONSISTENT WITH BOTULISM, ALSO CONSISTENT WITH FDA INSERT WARNING FOR BOTOX: HEART PALPITATIONS, SHALLOW BREATHING, TROUBLE SWALLOWING, TONGUE SWELLING, UNCONTROLLED TREMORS IN ARMS AND LEGS, HEAVY EYELIDS, MUSCLE WEAKNESS, NAUSEA, DIZZINESS, LIGHTHEADEDNESS. SYMPTOMS CONTINUED TO REOCCUR AND RESULTED IN REPEAT ER VISITS ON (B)(6) 2024 AND (B)(6) 2025. ER TESTS RULED OUT VIRAL ILLNESS, HEART CONDITIONS, AND OTHER CHRONIC CONDITIONS THAT WOULD SERVE AS ALTERNATIVE EXPLANATIONS FOR SAME SYMPTOMS. SYMPTOMS ARE STILL PRESENT ~1 MONTH LATER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2240639 RHA 3-1 SYRINGE IMPLANT, DERMAL, FOR AESTHETIC USE LMH REVANCE THERAPEUTICS, INC. (10)2348R3L0

    Patients

    Seq Age Sex Outcome Treatment
    1 41 YR Female Hospitalization| O| L| S ALBUTEROL INHALER AS NEEDED, | BOTOX COSMETIC.| DAILY MULTIVITAMIN.