BEUDAMED
    FDA Adverse Event Injury Summary report: N

    JUVEDERM (VOLUME/CONCENTRATION/ADDITIVE UNKNOWN)

    MDR report key: 12499699 · Received September 20, 2021

    Report

    Report Number
    3005113652-2021-03215
    Event Type
    Injury
    Date Received
    September 20, 2021
    Report Date
    September 20, 2021
    Manufacturer
    ALLERGAN (PRINGY)
    Product Code
    LMH
    PMA / PMN Number
    P050047
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE REPORTER HAS DECLINED TO PROVIDE ALLERGAN FURTHER INFORMATION REGARDING EVENT, PRODUCT, OR PATIENT DETAILS. THE EVENTS ARE PHYSIOLOGICAL COMPLICATIONS AND ANALYSIS OF THE DEVICE GENERALLY DOES NOT ASSIST ALLERGAN IN DETERMINING A PROBABLE CAUSE FOR THESE EVENTS. THE FILLER WAS INJECTED INTO THE PATIENT AND IS NOT ACCESSIBLE FOR RETURN. THE SYRINGE WAS NOT RETURNED FOR EVALUATION. THIS IS A KNOWN POTENTIAL ADVERSE EVENT ADDRESSED IN THE PRODUCT LABELING.

    Description of Event or Problem · 1

    PATIENT REPORTED THAT THEY WERE INJECTED WITH 2 SYRINGES OF UNSPECIFIED JUVÉDERM® IN CHEEKBONES, LIPS, AND IN CREASES AROUND MOUTH. APPROXIMATELY THREE MONTHS LATER, PATIENT WAS INJECTED IN CREASES AROUND MOUTH WITH 1 SYRINGE OF UNSPECIFIED JUVÉDERM®. WITHIN DAYS LATER, PATIENT REPORTED DEVELOPING HOT, SWELLING "LIKE A LARGE BOULDER" IN ONE CHEEK AND FULLER LIPS. PATIENT BELIEVES PREVIOUS FILLER IS REACTING WITH LATEST INJECTION. SYMPTOMS ONGOING. THIS IS THE SAME EVENT AND THE SAME PATIENT REPORTED UNDER MDR ID # 3005113652-2021-03214 (ALLERGAN COMPLAINT # (B)(4)). THIS MDR IS BEING SUBMITTED FOR THE SECOND SUSPECT INJECTION, JUVÉDERM®.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1395539 JUVEDERM (VOLUME/CONCENTRATION/ADDITIVE UNKNOWN) IMPLANT, DERMAL, FOR AESTHETIC USE LMH ALLERGAN (PRINGY) NI

    Patients

    Seq Age Sex Outcome Treatment
    1