BEUDAMED
    FDA Adverse Event Injury Summary report: N

    JUVEDERM VOLUX 2X1ML ROW

    MDR report key: 21955614 · Received May 2, 2025

    Report

    Report Number
    3005113652-2025-00413
    Event Type
    Injury
    Date Received
    May 2, 2025
    Date of Event
    September 7, 2024
    Report Date
    May 2, 2025
    Manufacturer
    PRINGY
    Product Code
    LMH
    UDI-DI
    7795316915751
    PMA / PMN Number
    P110033
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MX
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    CLARIFICATION TO H.6. TYPE OF INVESTIGATION CODE: THE FILLER WAS INJECTED INTO THE PATIENT AND IS NOT ACCESSIBLE FOR RETURN. THE SYRINGE WAS NOT RETURNED FOR EVALUATION. FURTHER INFORMATION REGARDING EVENT, PRODUCT, OR PATIENT DETAILS HAS BEEN REQUESTED. NO ADDITIONAL INFORMATION IS AVAILABLE AT THIS TIME. THE EVENT IS A PHYSIOLOGICAL COMPLICATION AND ANALYSIS OF THE DEVICE GENERALLY DOES NOT ASSIST ALLERGAN IN DETERMINING A PROBABLE CAUSE FOR THIS EVENT. A REVIEW OF THE DEVICE HISTORY RECORD HAS BEEN INITIATED. IF ANY NEW, CHANGED OR CORRECTED INFORMATION IS NOTED, A SUPPLEMENTAL MEDWATCH WILL BE SUBMITTED. THIS IS A KNOWN POTENTIAL ADVERSE EVENT ADDRESSED IN THE PRODUCT LABELING.

    Description of Event or Problem · 0

    HEALTHCARE PROFESSIONAL (HCP) REPORTED THAT A PATIENT INJECTED ON FIRST SESSION IN T1 (TEMPLE 0.5ML RIGHT, 0.7 ML LEFT ), CK1 (RIGHT 0.3 ML, 0.3 ML LEFT SIDE) & CK3 (0.3ML RIGHT SIDE, 0.5ML LEFT SIDE) WITH JUVÉDERM® VOLUMA¿ WITH LIDOCAINE, IN JW1 (0.5 ML RIGHT SIDE AND 0.5 ML LEFT SIDE) ,JW2 (0.5ML RIGHT SIDE, 0.5ML LEFT SIDE) WITH JUVÉDERM® VOLUX¿ AND IN C SHAPE (1.2ML ON EACH SIDE) WITH HARMONYCA¿. PATIENT HAVE EXPERIENCED "A TYPE OF DERMATITIS OR SCALING IN THE AREA WHERE HARMONYCA WAS ADMINISTERED." ADDITONAL INFORMATION PROVIDED, "ERYTHEMATOUS SQUAMOUS LESION IN THE APPLICATION AREA OF HYALURONIC ACID AND HARMONYCA (JW1, JW2 AND CK1) +, PRURIGINOUS +, WITHOUT EXUDATE, WITHOUT HEAT IN THE AREA." A COUPLE OF DAYS AFTER THE INJECTION, THE PATIENT REPORTS TO NOTICE MORE SEBUM PRODUCTION AT THE SKIN LEVEL. TWO DAYS LATER, ERYTHEMA, PRURITUS WITHOUT PAIN OR HEAT ARE ADDED TO THE AREA, WHICH RESOLVES WITH ADMINISTRATION OF 10 MG LORATADINE ORALLY FOR A SHORT PERIOD OF TIME AND RESOLVES THE CONDITION, ALSO ORAL ANTIHISTAMINES, LORATADINE 10 MG, LORATADINE WITH BETAMETHASONE. UNTIL, PATIENT REPORTED RECURRENCE OF ERYTHEMA, PRURITUS AND A THIN LAYER OF DESQUAMATION IN THE MIDDLE AREA OF THE CHEEK. THIS IS THE SAME EVENT AND THE SAME PATIENT REPORTED UNDER PATIENT IDENTIFIER (B)(6) (EMDR-(B)(4). THIS EMDR IS BEING SUBMITTED FOR THE SUSPECT PRODUCT, INJECTION IN JW1,JW2 (JAW) WITH JUVÉDERM® VOLUX¿.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    423681 JUVEDERM VOLUX 2X1ML ROW IMPLANT, DERMAL, FOR AESTHETIC USE LMH PRINGY 1000567280 7795316915751

    Patients

    Seq Age Sex Outcome Treatment
    1 45 YR Male Required Intervention