BEUDAMED
    FDA Adverse Event Injury Summary report: N

    JUVÉDERM VOLUMA WITH LIDOCAINE

    MDR report key: 16864877 · Received May 3, 2023

    Report

    Report Number
    3005113652-2023-00316
    Event Type
    Injury
    Date Received
    May 3, 2023
    Date of Event
    November 22, 2022
    Report Date
    June 22, 2023
    Manufacturer
    ALLERGAN (PRINGY)
    Product Code
    LMH
    UDI-DI
    05016007208092
    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

    CONTINUED H.6. HEALTH EFFECT - IMPACT CODE: F2203. CONTINUED H.6. INVESTIGATION CODE: B15, B17, B20. 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. THIS IS A KNOWN POTENTIAL ADVERSE EVENT ADDRESSED IN THE PRODUCT LABELING.

    Additional Manufacturer Narrative · 0

    ADDITIONAL, CORRECTED, AND/OR CHANGED DATA: H.8.

    Description of Event or Problem · 0

    HEALTHCARE PROFESSIONAL (HCP) REPORTED THAT A PATIENT EXPERIENCED ¿INFLAMMATION ON C1, ERYTHEMA, PAIN AND ABSCESS¿ 11 DAYS POST INJECTION IN C1 AND C2 WITH JUVÉDERM® VOLUX¿, IN T1 CK1 CK2 CK3 CK4 WITH JUVÉDERM® VOLUMA¿ WITH LIDOCAINE, AND IN NLS AND LPS WITH JUVÉDERM® VOLIFT¿ WITH LIDOCAINE. TREATMENT INCLUDED ¿AUGMENTINE 875/125 ZAMENE 60 HIALURONIDASA¿. SYMPTOMS RESOLVED. THIS IS THE SAME EVENT AND THE SAME PATIENT REPORTED UNDER MDR ID# 3005113652-2023-00317(ALLERGAN COMPLAINT (B)(4)) AND MDR ID#3005113652-2023-00315(ALLERGAN COMPLAINT (B)(4)). THIS MDR IS BEING SUBMITTED FOR THE FIRST SUSPECT PRODUCT, JUVÉDERM® VOLUMA¿.

    Description of Event or Problem · 0

    HEALTHCARE PROFESSIONAL (HCP) REPORTED THAT A PATIENT EXPERIENCED ¿INFLAMMATION ON C1, ERYTHEMA, PAIN AND ABSCESS¿ 11 DAYS POST INJECTION IN C1 AND C2 WITH JUVÉDERM® VOLUX¿, IN T1 CK1 CK2 CK3 CK4 WITH JUVÉDERM® VOLUMA¿ WITH LIDOCAINE, AND IN NLS AND LPS WITH JUVÉDERM® VOLIFT¿ WITH LIDOCAINE. TREATMENT INCLUDED ¿AUGMENTINE 875/125 ZAMENE 60 HIALURONIDASA¿. SYMPTOMS RESOLVED. THIS IS THE SAME EVENT AND THE SAME PATIENT REPORTED UNDER MDR ID# 3005113652-2023-00317 (ALLERGAN COMPLAINT #(B)(4) AND MDR ID#3005113652-2023-00315(ALLERGAN COMPLAINT #(B)(4)). THIS MDR IS BEING SUBMITTED FOR THE FIRST SUSPECT PRODUCT, JUVÉDERM® VOLUMA¿.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    433428 JUVÉDERM VOLUMA WITH LIDOCAINE IMPLANT, DERMAL, FOR AESTHETIC USE LMH ALLERGAN (PRINGY) VB20B10933 05016007208092

    Patients

    Seq Age Sex Outcome Treatment
    1 Female Required Intervention