BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNK JUVEDERM VOLITE

    MDR report key: 23751627 · Received December 8, 2025

    Report

    Report Number
    3005113652-2025-01117
    Event Type
    Injury
    Date Received
    December 8, 2025
    Date of Event
    November 5, 2025
    Report Date
    December 8, 2025
    Manufacturer
    PRINGY
    Product Code
    LMH
    PMA / PMN Number
    P110033
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    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. THE EVENT OF "INDUCED ABORTION", DEEMED NOT DEVICE RELATED, IS CONSIDERED AN UNEXPECTED ADVERSE DRUG EXPERIENCE.

    Description of Event or Problem · 0

    HEALTHCARE PROFESSIONAL REPORTED INJECTING A CLINICAL PATIENT IN THE CHEEKS WITH 2 ML AND IN THE PERIORAL AREA WITH 1 ML OF JUVÉDERM® VOLITE¿. A MONTH LATER, THE PATIENT WAS INJECTED IN THE CHEEKS WITH 2 ML AND IN THE PERIORAL AREA WITH 1 ML OF JUVÉDERM® VOLITE¿. FOUR MONTHS LATER, THE PATIENT EXPERIENCED NON-DEVICE RELATED ¿HELICOBACTER PYLORI INFECTION,¿ ¿INTESTINAL FLORA IMBALANCE,¿ AND ¿REFLUX ESOPHAGITIS AGGRAVATED¿ AND WAS TREATED THAT DAY WITH ALUMINUM MAGNESIUM CARBONATE CHEWABLE TABLETS AMOXICILLIN CAPSULES 500 MG TID, AMOXICILLIN CAPSULES 1 G TID, SACCHAROMYCES BOULARDII POWDER 0.5 G BID, AND FUMARATE VORONASONE TABLETS 50 MG BIM. NINE DAYS LATER, THE PATIENT EXPERIENCED ¿ALLERGIC RHINITIS¿ AND WAS TREATED THAT DAY WITH EBASTINE TABLETS 10 MG QN AND GLYCINOMETHAMINE NASAL SPRAY 1 UNIT TID. A WEEK LATER, THE ¿HELICOBACTER PYLORI INFECTION,¿ ¿INTESTINAL FLORA IMBALANCE,¿ AND ¿REFLUX ESOPHAGITIS¿ RESOLVED, AND THE PATIENT WAS TREATED WITH DESLORATADINE CITRATE TABLETS 8.8 G QN FOR THE ¿ALLERGIC RHINITIS.¿ THE EVENT RESOLVED 3 MONTHS LATER. TWELVE DAYS LATER, THE PATIENT EXPERIENCED NON-DEVICE RELATED ¿AGGRAVATED INSOMNIA¿ AND WAS TREATED THAT DAY WITH ZOLPIDEM TABLETS 10 MG. THE EVENT RESOLVED 6 DAYS LATER. FIVE MONTHS LATER, THE PATIENT HAD A NON-DEVICE RELATED ¿INDUCED ABORTION¿ THAT RESOLVED THE DAY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2774222 UNK JUVEDERM VOLITE IMPLANT, DERMAL, FOR AESTHETIC USE LMH PRINGY NI

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Female