BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RESTYLANE LYFT AND RESTYLANE DEFYNE

    MDR report key: 11201404 · Received January 19, 2021

    Report

    Report Number
    MW5098887
    Event Type
    Injury
    Date Received
    January 19, 2021
    Date of Event
    February 21, 2020
    Report Date
    January 15, 2021
    Manufacturer
    GALDERMA LABORATORIES, L.P.
    Product Code
    LMH
    Adverse Event
    Yes
    Report Source
    Voluntary report
    Reporter Location
    FL, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    I WAS GETTING FILLERS FOR FACIAL WRINKLES. I HAD REPORTED THAT (B)(6) WAS THE ONLY FILLER THAT WAS APPROPRIATE BUT DOCTOR SAYS THERE IS NO DOCUMENTATION OF THAT IN MY HEALTH RECORD. I WAS GIVEN RESTYLANE FILLERS AT THE TIME. BY THE END OF SEPTEMBER I HAD ONE LARGE BUMP ON THE LEFT CHEEK AND SMALLER ONES AROUND MY FACE. I SAW A DERMATOLOGIST WHO SENT ME TO A PLASTIC SURGEON. THE DERMATOLOGIST SAID IT WAS A LIPOMA. THE PLASTIC SURGEON FELT IT AND SAID HE DID NOT THINK IT WAS A LIPOMA AND DID AND EXCISION: LIPOMA VS. EPIDERMOID INCLUSION CYST ON LEFT INFERIOR MEDIAL MALARIA CHEEK. RESULTS: FOREIGN BODY GIANT CELL REACTION TO FILLER MATERIAL. NO MALIGNANCY SEEN. I THEN SAW A DERMATOLOGIST FOR SECOND OPINION WHO HAD TO INJECT SEVERAL UNITS TO REMOVE OTHER RESTYLANE BUMPS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    95466 RESTYLANE LYFT AND RESTYLANE DEFYNE IMPLANT, DERMAL, FOR AESTHETIC USE LMH GALDERMA LABORATORIES, L.P.

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR