BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SCULPRA

    MDR report key: 21986009 · Received May 8, 2025

    Report

    Report Number
    MW5170107
    Event Type
    Injury
    Date Received
    May 8, 2025
    Date of Event
    May 24, 2024
    Report Date
    May 6, 2024
    Manufacturer
    GALDERMA LABORATORIES, L.P.
    Product Code
    LMH
    Adverse Event
    Yes
    Report Source
    Voluntary report
    Reporter Location
    FL, US
    Reporter Occupation
    PATIENT
    Health Professional
    *

    Narratives

    Description of Event or Problem · 0

    I RECEIVED BOTOX AND SCULPTRA ON (B)(6) 2024. ON (B)(6) 2024 I ALMOST DIED. MY THROAT CLOSED UP, MY HEART RATE WAS ELEVATED TO ABOVE 160 BPM, SEVERE HEADACHE, DRY MOUTH, SHAKINESS, WEAKNESS, TINGLING ON MY HEAD, BLURRED VISION, SENSITIVITY TO LIGHT, SEVERE PANIC ATTACK, VERTIGO, DIZZINESS, SENSITIVITY TO HEAT AND RINGING OF THE EARS. THIS LED TO 11 TRIPS TO THE EMERGENCY ROOM (ER), WITH 2 OVERNIGHT STAYS. I SAW A VARIETY OF SPECIALISTS INCLUDING CARDIOLOGIST, EARS, NOSE, THROAT (ENT), ENDOCRINOLOGIST, DID A HEARING EXAM, HAD A COMPUTED TOMOGRAPHY (CT) SCAN OF THE BRAIN, ULTRASOUND OF THE ABDOMINAL CAVITY, DID A STRESS TEST, ELECTROCARDIOGRAM (EKG) AND ECHO. MY THYROID LEVELS KEPT GOING UP AND DOWN (NO PREVIOUS ISSUES WITH THYROID). ALL BLOOD WORK LOOKED NORMAL. HAPPY TO SHARE MY MEDICAL RECORDS FOR FURTHER INVESTIGATION. REFERENCE REPORT: MW5170106.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    346491 SCULPRA IMPLANT, DERMAL, FOR AESTHETIC USE LMH GALDERMA LABORATORIES, L.P.

    Patients

    Seq Age Sex Outcome Treatment
    1 38 YR Female Hospitalization