BEUDAMED
    FDA Adverse Event Injury Summary report: N

    JUVEDERM VOLUX 2X1ML EAME SKU1

    MDR report key: 21225555 · Received January 23, 2025

    Report

    Report Number
    3005113652-2025-00068
    Event Type
    Injury
    Date Received
    January 23, 2025
    Date of Event
    January 13, 2025
    Report Date
    February 19, 2025
    Manufacturer
    PRINGY
    Product Code
    LMH
    PMA / PMN Number
    P110033
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SP
    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. THE EVENT OF "MASTITIS", DEEMED NOT DEVICE RELATED IS CONSIDERED AN UNEXPECTED ADVERSE DRUG EXPERIENCE.

    Additional Manufacturer Narrative · 0

    ADDITIONAL, CORRECTED, AND/OR CHANGED DATA: B5, H6.

    Description of Event or Problem · 0

    HEALTHCARE PROFESSIONAL REPORTED A PATIENT WAS INJECTED WITH JUVÉDERM® VOLUX¿ IN THE C1, C4, C6. PATIENT EXPERIENCED INFLAMMATION. MODERATE INFLAMMATION OF THE CHIN. IN TREATMENT FOR NON-DEVICE RELATED ACUTE MASTITIS, ALSO FEVER, IN TREATMENT WITH AMOXICILLIN 1 GR EVERY 8 HOURS. EXPLORATION: MILD INDURATION OF THE CHIN NON GENERALIZED. ULTRASOUND: MILD EDEMA. COLLECTION NOT OBSERVED. MORE PAINFUL AREAS C6 AND C2. NO SIGNS OF ACUTE INFLAMMATION OR CREPITATION. ZAMENE 30 EVERY 12 HOURS, AMOXICILLIN 1 GR EVERY 8 HOURS. SYMPTOMS ON GOING.

    Description of Event or Problem · 0

    HEALTHCARE PROFESSIONAL LATER REPORTED SYMPTOMS HAVE RESOLVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    555197 JUVEDERM VOLUX 2X1ML EAME SKU1 IMPLANT, DERMAL, FOR AESTHETIC USE LMH PRINGY 1001164217

    Patients

    Seq Age Sex Outcome Treatment
    1 38 YR Male Required Intervention