BEUDAMED
    FDA Adverse Event Injury Summary report: N

    JUVEDERM VOLUMA (VOLUME/ADDITIVE UNKNOWN)

    MDR report key: 23237760 · Received October 7, 2025

    Report

    Report Number
    3005113652-2025-00889
    Event Type
    Injury
    Date Received
    October 7, 2025
    Date of Event
    August 15, 2025
    Report Date
    October 7, 2025
    Manufacturer
    PRINGY
    Product Code
    LMH
    PMA / PMN Number
    P110033
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    003

    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. THIS IS A KNOWN POTENTIAL ADVERSE EVENT ADDRESSED IN THE PRODUCT LABELING.

    Description of Event or Problem · 0

    HEALTHCARE PROFESSIONAL (HCP) REPORTED INJECTING A PATIENT WITH [UNSPECIFIED] JUVÉDERM® VOLUMA¿. APPROXIMATELY 2 WEEKS POST INJECTION, PATIENT BEGAN TO EXPERIENCE "REDNESS, SLIGHT SWELLING AND TENDERNESS UPON TOUCH TO LEFT MID CHEEK". HCP NOTED UPON EXAMINATION PATIENT HAD LOCALIZED ERYTHEMA AND SLIGHT OEDEMA. HCP STATES THE SYMPTOMS ARE "LIKELY LOCALIZED INFLAMMATORY RESPONSE/ LOW GRADE INFECTION FOLLOWING DERMAL FILLER". PATIENT WAS TREATED WITH 500MG FLUCLOXACILLIN QDS FOR 1 WEEK. UPON REVIEW AT THE END OF TREATMENT, PATIENT WAS NO LONGER EXPERIENCING ANY SYMPTOMS. APPROXIMATELY 2 WEEKS LATER, PATIENT CONTACTED THE HCP EXPRESSING CONCERNS ABOUT "CLEAR SEROUS FLUID DISCHARGE" AT THE SAME AREA. HCP STATES THE DISCHARGE HAS STOPPED AND WAS UNABLE TO TAKE A SWAB FOR TESTING. PATIENT NOTED FEELING SOME PRESSURE IN THE AREA PRIOR TO THE DISCHARGE, BUT UPON DISCHARGE PRESSURE WAS RELIEVED. SMALL AREA OF REDNESS WAS NOTED IN THE AREA OF DISCHARGE. HCP TREATED THE PATIENT WITH FLUCLOXACILLIN 500MG QDS. PATIENT CONTACTED THE HCP TO STATE THERE HAVE BEEN "A COUPLE OF INSTANCES OF SEROUS FLUID FROM THE AFFECTED SITE" WHICH HAS DRIED UP AND COULD NOT BE SWABBED. SYMPTOMS ARE ONGOING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1439562 JUVEDERM VOLUMA (VOLUME/ADDITIVE UNKNOWN) IMPLANT, DERMAL, FOR AESTHETIC USE LMH PRINGY NI

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention