BEUDAMED
    FDA Adverse Event Injury Summary report: N

    JUVEDERM VOLUMA WITH LIDOCAINE 1 ML

    MDR report key: 22722625 · Received August 5, 2025

    Report

    Report Number
    3005113652-2025-00713
    Event Type
    Injury
    Date Received
    August 5, 2025
    Date of Event
    June 11, 2025
    Report Date
    August 26, 2025
    Manufacturer
    PRINGY
    Product Code
    LMH
    UDI-DI
    30888628000128
    PMA / PMN Number
    P110033
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    A REVIEW OF THE DEVICE HISTORY RECORD HAS BEEN COMPLETED. NO DEVIATIONS OR NON-CONFORMANCES NOTED.

    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 REPORTED THAT PATIENT INJECTED WITH (1CC) JUVÉDERM® VOLUMA® WITH LIDOCAINE IN T1,T2, (3CC) JUVÉDERM® VOLUMA® WITH LIDOCAINE IN THE "F", (2CC) JUVÉDERM® VOLIFT® WITH LIDOCAINE IN CK1,CK3,CK4, (1CC) JUVÉDERM® VOLUX¿ IN C1,C2,C6, (2CC) SKINVIVE¿ BY JUVÉDERM® IN FRONT CHEEK (L/R), (1CC) SKINVIVE¿ BY JUVÉDERM® IN TT1,TT2. PATIENT EXPERIENCED "DELAYED IMMUNE RESPONSE" APPROXIMATELY 2 MONTHS AFTER INJECTION. TREATMENT INCLUDED UNSPECIFIED PRESCRIPTION OF MEDICATION, FILLER DISSOLVE (FILLER MELT) BY USING HYALASE 4VIAL AND NODULATION TREATMENT TWO ROUND. SYMPTOMS ONGOING/UNRESOLVED. THIS IS THE SAME EVENT AND THE SAME PATIENT REPORTED UNDER PATIENT IDENTIFIER (B)(6) THIS EMDR IS BEING SUBMITTED FOR THE SUSPECT PRODUCT, (1CC) JUVÉDERM® VOLUMA® WITH LIDOCAINE IN T1, T2.

    Description of Event or Problem · 0

    HEALTHCARE PROFESSIONAL REPORTED THAT PATIENT INJECTED WITH (1CC) JUVÉDERM® VOLUMA® WITH LIDOCAINE IN T1,T2, (3CC) JUVÉDERM® VOLUMA® WITH LIDOCAINE IN THE "F", (2CC) JUVÉDERM® VOLIFT® WITH LIDOCAINE IN CK1,CK3,CK4, (1CC) JUVÉDERM® VOLUX¿ IN C1,C2,C6, (2CC) SKINVIVE¿ BY JUVÉDERM® IN FRONT CHEEK (L/R), (1CC) SKINVIVE¿ BY JUVÉDERM® IN TT1,TT2. PATIENT EXPERIENCED "DELAYED IMMUNE RESPONSE" APPROXIMATELY 2 MONTHS AFTER INJECTION. TREATMENT INCLUDED UNSPECIFIED PRESCRIPTION OF MEDICATION, FILLER DISSOLVE(FILLER MELT) BY USING HYALASE 4VIAL AND NODULATION TREATMENT TWO ROUND. SYMPTOMS ONGOING/UNRESOLVED. THIS IS THE SAME EVENT AND THE SAME PATIENT REPORTED UNDER PATIENT IDENTIFIER (B)(6) (EMDR-(B)(4), (B)(6) (EMDR-(B)(4), (B)(6) (EMDR-(B)(4), (B)(6) (EMDR-(B)(4), (B)(6) (EMDR-(B)(4). THIS EMDR IS BEING SUBMITTED FOR THE SUSPECT PRODUCT, (1CC) JUVÉDERM® VOLUMA® WITH LIDOCAINE IN T1, T2.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1288181 JUVEDERM VOLUMA WITH LIDOCAINE 1 ML IMPLANT, DERMAL, FOR AESTHETIC USE LMH PRINGY 1000864914 30888628000128

    Patients

    Seq Age Sex Outcome Treatment
    1 48 YR Female Required Intervention