BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RESTYLANE LYFT

    MDR report key: 11207388 · Received January 20, 2021

    Report

    Report Number
    MW5098903
    Event Type
    Injury
    Date Received
    January 20, 2021
    Date of Event
    January 5, 2021
    Report Date
    January 16, 2021
    Manufacturer
    GALDERMA/ GALDERMA LABORATORIES, L.P.
    Product Code
    LMH
    Adverse Event
    Yes
    Report Source
    Voluntary report
    Reporter Location
    US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    RECEIVED 3ML. OF RESTYLANE LYFT (MANUFACTURED BY GALDERMA) IN CHEEKS + CHIN ON (B)(6) 2021. SIX (6) HOURS AFTER BEGAN EXPERIENCING INTENSE SWEATING, ON/OFF LOW-GRADE FEVER, RAPID HEART RATE (DESPITE LAYING DOWN), DIZZINESS, AND NAUSEA. AFTER APPROXIMATELY ONE (1) HOUR OF SYMPTOM ONSET, WAS FOLLOWED BY SEVERE VOMITING AND SYNCOPE. NOTE- NO FOOD OR BEVERAGE OTHER THAN CRACKERS, AN APPLE, AND 1 LITER WATER CONSUMED IN THE 6 HOURS LEADING UP TO THE SYMPTOMS ONSET POST INJECTIONS. NO MEDICATIONS (OTC OR RX) WERE TAKEN POST INJECTIONS LEADING UP TO SYMPTOM ONSET. FOLLOWING SYNCOPE + VOMITING, WAS ADVISED BY THE PRACTICE (WHERE I RECEIVED INJECTIONS) NURSE PRACTITIONER TO TAKE BENADRYL (25MG) + 4MG TABLET OF ZOFRAN. APPROXIMATELY 30 MINUTES AFTER TAKING THE ZOFRAN + BENADRYL ALL SYMPTOMS DID GO AWAY. SERIAL NUMBERS (AND ALL OTHER NECESSARY INFORMATION FROM MANUFACTURER) PERTAINING TO THE SYRINGES USED PRIOR TO ADVERSE SYMPTOMS BEGINNING ARE DOCUMENTED, AND I HAVE THEM READILY AVAILABLE UPON REQUEST. DID THE PROBLEM STOP AFTER THE PERSON REDUCED THE DOSE OR STOPPED TAKING OR USING THE PRODUCT? NO. COSMETIC TREATMENT - ADD FULLNESS TO CHEEKS + CHIN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    101820 RESTYLANE LYFT IMPLANT, DERMAL, FOR AESTHETIC USE LMH GALDERMA/ GALDERMA LABORATORIES, L.P.

    Patients

    Seq Age Sex Outcome Treatment
    1 32 YR