BEUDAMED
    FDA Adverse Event Death Summary report: N

    JUVEDERM (VOLUME/CONCENTRATION/ADDITIVE UNKNOWN)

    MDR report key: 21774930 · Received April 4, 2025

    Report

    Report Number
    3005113652-2025-00314
    Event Type
    Death
    Date Received
    April 4, 2025
    Report Date
    April 4, 2025
    Manufacturer
    PRINGY
    Product Code
    LMH
    PMA / PMN Number
    P050047
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    CLARIFICATION TO H6: TYPE OF INVESTIGATION CODE: THE FILLER WAS INJECTED INTO THE PATIENT AND IS NOT ACCESSIBLE FOR RETURN. THE SYRINGE WAS NOT RETURNED FOR EVALUATION. THE EVENT IS A PHYSIOLOGICAL COMPLICATION AND ANALYSIS OF THE DEVICE GENERALLY DOES NOT ASSIST ABBVIE IN DETERMINING A PROBABLE CAUSE FOR THIS EVENT. FURTHER INFORMATION REGARDING EVENT, PRODUCT, OR PATIENT DETAILS HAS BEEN REQUESTED. NO ADDITIONAL INFORMATION IS AVAILABLE AT THIS TIME. ANAPHYLAXIS A KNOWN POTENTIAL ADVERSE EVENT ADDRESSED IN THE PRODUCT LABELING.

    Description of Event or Problem · 0

    HEALTHCARE PROFESSIONAL (HCP) REPORTED A PATIENT DIED OF ANAPHYLAXIS FROM BOTOX® AND UNSPECIFIED JUVÉDERM PRODUCT. THE PATIENT RECEIVED BOTOX® AND UNSPECIFIED JUVÉDERM PRODUCT AT THEIR HOME AND LATER WENT INTO THE HOSPITAL WITH ANAPHYLAXIS AND THEY THOUGHT THE PATIENT HAD A HEART ATTACK BUT THEN SAID IT WAS AN ALLERGIC REACTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    633529 JUVEDERM (VOLUME/CONCENTRATION/ADDITIVE UNKNOWN) IMPLANT, DERMAL, FOR AESTHETIC USE LMH PRINGY NI

    Patients

    Seq Age Sex Outcome Treatment
    1 59 YR Female Death