BEUDAMED
    FDA Adverse Event Injury Summary report: N

    JUVÉDERM VOLUMA WITH LIDOCAINE

    MDR report key: 16452513 · Received February 28, 2023

    Report

    Report Number
    3005113652-2023-00133
    Event Type
    Injury
    Date Received
    February 28, 2023
    Date of Event
    February 7, 2023
    Report Date
    June 13, 2023
    Manufacturer
    ALLERGAN (PRINGY)
    Product Code
    LMH
    UDI-DI
    05016007208092
    PMA / PMN Number
    P110033
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PO
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    ADDITIONAL, CHANGED, AND/OR CORRECTED DATA: B1, H6.

    Additional Manufacturer Narrative · 0

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

    Additional Manufacturer Narrative · 0

    TYPE OF INVESTIGATION CODE: B15, B17, B20. TYPE OF INVESTIGATION CODE: THE FILLER WAS INJECTED INTO THE PATIENT AND IS NOT ACCESSIBLE FOR RETURN. THE SYRINGE WAS NOT RETURNED FOR EVALUATION. THE EVENT IS A PHYSIOLOGICAL COMPLICATION AND ANALYSIS OF THE DEVICE GENERALLY DOES NOT ASSIST ALLERGAN IN DETERMINING A PROBABLE CAUSE FOR THIS EVENT. FURTHER INFORMATION REGARDING EVENT, PRODUCT, OR PATIENT DETAILS HAS BEEN REQUESTED. NO ADDITIONAL INFORMATION IS AVAILABLE AT THIS TIME. 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 INFLAMMATORY NODULE IS A KNOWN POTENTIAL ADVERSE EVENT ADDRESSED IN THE PRODUCT LABELING.

    Description of Event or Problem · 0

    SYMPTOMS HAVE RESOLVED.

    Description of Event or Problem · 0

    HEALTHCARE PROFESSIONAL (HCP) REPORTED INJECTING A PATIENT WITH 1ML OF JUVÉDERM® VOLIFT¿ WITH LIDOCAINE INTO THE CK3 SOOT AND 2 ML OF JUVÉDERM® VOLUMA¿ WITH LIDOCAINE INTO THE CK1, CK3 AND CK4. FOUR MONTHS LATER, PATIENT WAS INJECTED WITH 1ML OF JUVÉDERM® VOLUMA¿ WITH LIDOCAINE AND 1ML OF JUVÉDERM® VOLBELLA¿ WITH LIDOCAINE INTO T1, TT1, TT2 AND TT3. APPROXIMATELY TWO AND A HALF MONTHS LATER, PATIENT EXPERIENCED LATE INFLAMMATORY NODULES AND EDEMA IN CK1 AND CK3 (A WEEK AFTER EXPERIENCING SOME VIRAL SYMPTOMS). PATIENT WAS TREATED WITH DEFLAZACORT (FOR 3 WEEKS, ACCORDING TO PROTOCOL), AND CIPROFLOXACINA 750. SYMPTOMS HAVE NOT BEEN RESOLVED.

    Description of Event or Problem · 0

    HEALTHCARE PROFESSIONAL (HCP) REPORTED INJECTING A PATIENT WITH 1ML OF JUVÉDERM® VOLIFT¿ WITH LIDOCAINE INTO THE CK3 SOOT AND 2 ML OF JUVÉDERM® VOLUMA¿ WITH LIDOCAINE INTO THE CK1, CK3 AND CK4. FOUR MONTHS LATER, PATIENT WAS INJECTED WITH 1ML OF JUVÉDERM® VOLUMA¿ WITH LIDOCAINE AND 1ML OF JUVÉDERM® VOLBELLA¿ WITH LIDOCAINE INTO T1, TT1, TT2 AND TT3. APPROXIMATELY TWO AND A HALF MONTHS LATER, PATIENT EXPERIENCED LATE INFLAMMATORY NODULES AND EDEMA IN CK1 AND CK3 (A WEEK AFTER EXPERIENCING SOME VIRAL SYMPTOMS). PATIENT WAS TREATED WITH DEFLAZACORT (FOR 3 WEEKS, ACCORDING TO PROTOCOL), AND CIPROFLOXACINA 750. SYMPTOMS HAVE NOT BEEN RESOLVED. THIS IS THE SAME EVENT AND THE SAME PATIENT REPORTED UNDER MDR ID# 3005113652-2023-00132 (ALLERGAN COMPLAINT # (B)(4)), MDR ID# 3005113652-2023-00131 (ALLERGAN COMPLAINT # (B)(4)), MDR ID# 3005113652-2023-00134 (ALLERGAN COMPLAINT # (B)(4)). THIS MDR IS BEING SUBMITTED FOR THE THIRD SUSPECT PRODUCT, JUVÉDERM® VOLUMA¿ WITH LIDOCAINE.

    Description of Event or Problem · 0

    HEALTHCARE PROFESSIONAL (HCP) REPORTED INJECTING A PATIENT WITH 1ML OF JUVÉDERM® VOLIFT¿ WITH LIDOCAINE INTO THE CK3 SOOT AND 2 ML OF JUVÉDERM® VOLUMA¿ WITH LIDOCAINE INTO THE CK1, CK3 AND CK4. FOUR MONTHS LATER, PATIENT WAS INJECTED WITH 1ML OF JUVÉDERM® VOLUMA¿ WITH LIDOCAINE AND 1ML OF JUVÉDERM® VOLBELLA¿ WITH LIDOCAINE INTO T1, TT1, TT2 AND TT3. APPROXIMATELY TWO AND A HALF MONTHS LATER, PATIENT EXPERIENCED LATE INFLAMMATORY NODULES AND EDEMA IN CK1 AND CK3 (A WEEK AFTER EXPERIENCING SOME VIRAL SYMPTOMS). PATIENT WAS TREATED WITH DEFLAZACORT (FOR 3 WEEKS, ACCORDING TO PROTOCOL), AND CIPROFLOXACINA 750. SYMPTOMS HAVE NOT BEEN RESOLVED. THIS IS THE SAME EVENT AND THE SAME PATIENT REPORTED UNDER MDR ID# 3005113652-2023-00132 (ALLERGAN COMPLAINT #(B)(4)), MDR ID# 3005113652-2023-00131 (ALLERGAN COMPLAINT #(B)(4)), MDR ID# 3005113652-2023-00134 (ALLERGAN COMPLAINT #(B)(4)). THIS MDR IS BEING SUBMITTED FOR THE THIRD SUSPECT PRODUCT, JUVÉDERM® VOLUMA¿ WITH LIDOCAINE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    398777 JUVÉDERM VOLUMA WITH LIDOCAINE IMPLANT, DERMAL, FOR AESTHETIC USE LMH ALLERGAN (PRINGY) VB20B10903 05016007208092

    Patients

    Seq Age Sex Outcome Treatment
    1 48 YR Female Required Intervention| O JUVÉDERM® VOLBELLA¿ WITH LIDOCAINE