BEUDAMED
    FDA Adverse Event Injury Summary report: N

    JUVEDERM VOLUMA WITH LIDOCAINE

    MDR report key: 17865531 · Received October 3, 2023

    Report

    Report Number
    3005113652-2023-00786
    Event Type
    Injury
    Date Received
    October 3, 2023
    Date of Event
    March 7, 2023
    Report Date
    November 20, 2023
    Manufacturer
    ALLERGAN (PRINGY)
    Product Code
    LMH
    PMA / PMN Number
    P110033
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    DA
    Reporter Occupation
    NURSE
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    CLARIFICATION TO E.1. POSTAL CODE: (B)(6). 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.

    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 LATER NOTED TREATMENT AS "MOXIFLOXACIN 400 MG X 1 DAILY, AZITHROMYCIN 250 MG X 1 DAILY FOR 2 WEEKS, AND HYALASE X 1 WEEKLY. IF THERE IS NO EFFECT IN 3 WEEKS, A SHORT-TERM COURSE OF PREDNISOLONE MAY BE NECESSARY.

    Description of Event or Problem · 0

    HEALTHCARE PROFESSIONAL (HCP) REPORTED PATIENT WAS INJECTED WITH [UNSPECIFIED] JUVÉDERM® VOLUMA¿ IN C1, CK1, CK4/JW2, [UNSPECIFIED] JUVÉDERM® VOLIFT¿ IN CK3, AND JUVÉDERM® VOLUX¿ IN JW1, JW4/JW5, C6. THREE MONTHS LATER, PATIENT EXPERIENCED ¿SWOLLEN NODULES BILATERALLY AT THE JAW" THAT ¿FELT LIKE LITTLE HARD KNOTS." HCP PERFORMED FINE NEEDLE BIOPSIES THAT "SHOW SIGNS OF FOREIGN BODY REACTION AS WELL AS FILLER MATERIAL." HCP STATES THEY ARE "ALSO FAMILIAR WITH MB. SJOGREN AND AWAITS RHEUMATOLOGISTS BECAUSE OF SYMPTOMS OF THE ILLNESS." HCP NOTES 3 NODULES. NODULES BY WOE. JAW EDGE AND 1 BY HAY. JAW EDGE. THE ELEMENTS ARE VOLATILE AND TENDER. TREATMENT NOTED "PLAN HAS BEEN MADE, WHICH HAS BEEN STARTED AND THE PATIENT IS FOLLOWED." SYMPTOMS ONGOING. HEALTHCARE PROFESSIONAL LATER NOTED TREATMENT AS "MOXIFLOXACIN 400 MG X 1 DAILY, AZITHROMYCIN 250 MG X 1 DAILY FOR 2 WEEKS, AND HYALASE X 1 WEEKLY. IF THERE IS NO EFFECT IN 3 WEEKS, A SHORT-TERM COURSE OF PREDNISOLONE MAY BE NECESSARY. THIS IS THE SAME EVENT AND THE SAME PATIENT REPORTED UNDER MDR ID# 3005113652-2023-00788 (ALLERGAN COMPLAINT #(B)(4)) AND MDR ID# 3005113652-2023-00787 (ALLERGAN COMPLAINT #(B)(4)). THIS MDR IS BEING SUBMITTED FOR THE FIRST SUSPECT PRODUCT, [UNSPECIFIED] JUVÉDERM® VOLUMA¿.

    Description of Event or Problem · 0

    HEALTHCARE PROFESSIONAL (HCP) REPORTED PATIENT WAS INJECTED WITH [UNSPECIFIED] JUVÉDERM® VOLUMA¿ IN C1, CK1, CK4/JW2, [UNSPECIFIED] JUVÉDERM® VOLIFT¿ IN CK3, AND JUVÉDERM® VOLUX¿ IN JW1, JW4/JW5, C6. THREE MONTHS LATER, PATIENT EXPERIENCED ¿SWOLLEN NODULES BILATERALLY AT THE JAW" THAT ¿FELT LIKE LITTLE HARD KNOTS." HCP PERFORMED FINE NEEDLE BIOPSIES THAT "SHOW SIGNS OF FOREIGN BODY REACTION AS WELL AS FILLER MATERIAL." HCP STATES THEY ARE "ALSO FAMILIAR WITH MB. SJOGREN AND AWAITS RHEUMATOLOGISTS BECAUSE OF SYMPTOMS OF THE ILLNESS." HCP NOTES 3 NODULES. NODULES BY WOE. JAW EDGE AND 1 BY HAY. JAW EDGE. THE ELEMENTS ARE VOLATILE AND TENDER. TREATMENT NOTED "PLAN HAS BEEN MADE, WHICH HAS BEEN STARTED AND THE PATIENT IS FOLLOWED." SYMPTOMS ONGOING. THIS IS THE SAME EVENT AND THE SAME PATIENT REPORTED UNDER MDR ID# 3005113652-2023-00788 (ALLERGAN COMPLAINT#: (B)(4) AND MDR ID# 3005113652-2023-00787 (ALLERGAN COMPLAINT#: (B)(4). THIS MDR IS BEING SUBMITTED FOR THE FIRST SUSPECT PRODUCT, [UNSPECIFIED] JUVÉDERM® VOLUMA¿.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    589749 JUVEDERM VOLUMA WITH LIDOCAINE IMPLANT, DERMAL, FOR AESTHETIC USE LMH ALLERGAN (PRINGY) VB20B10545

    Patients

    Seq Age Sex Outcome Treatment
    1 36 YR Female Required Intervention