BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNK JUVEDERM VOLUX

    MDR report key: 18871531 · Received March 8, 2024

    Report

    Report Number
    3005113652-2024-11030
    Event Type
    Injury
    Date Received
    March 8, 2024
    Date of Event
    February 18, 2024
    Report Date
    April 24, 2024
    Manufacturer
    ALLERGAN (PRINGY)
    Product Code
    LMH
    PMA / PMN Number
    P110033
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BR
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    ADDITIONAL, CHANGED, AND/OR CORRECTED DATA.

    Additional Manufacturer Narrative · 0

    CONTINUED D.10. CONCOMITANT THERAPIES: JUVÉDERM® VOLITE¿ 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. THE EVENT IS A PHYSIOLOGICAL COMPLICATION AND ANALYSIS OF THE DEVICE GENERALLY DOES NOT ASSIST ABBVIE IN DETERMINING A PROBABLE CAUSE FOR THIS EVENT. THE EVENT OF DENGUE (INFECTION), DEEMED NOT DEVICE RELATED IS CONSIDERED AN UNEXPECTED ADVERSE DRUG EXPERIENCE.

    Description of Event or Problem · 0

    ADDITIONALLY, THE PATIENT WAS TREATED WITH DIPYRONE 1 G QID X 4 A DAY ON THE SAME DAY OF ONSET.

    Description of Event or Problem · 0

    HEALTHCARE PROFESSIONAL REPORTED A PATIENT WAS INJECTED WITH 4.47MLS OF HARMONYCA WITH LIDOCAINE INTO THE ZYGOMATIC AND MANDIBULAR, THEN A MONTH LATER INJECTED WITH 1.25MLS OF HARMONYCA WITH LIDOCAINE INTO THE ZYGOMATIC AND MANDIBULAR. A MONTH LATER, PATIENT WAS INJECTED WITH 4MLS OF JUVÉDERM® VOLUMA¿ WITH LIDOCAINE INTO THE CHEEKS, TEMPLE AND CHIN, AND 1.5MLS OF JUVÉDERM® VOLUX¿ WITH LIDOCAINE INTO THE CHIN AND JAW. A MONTH LATER, PATIENT RECEIVED 1ML OF JUVÉDERM® VOLITE¿ INTO THE NASOLABIAL, GLABELLA, CHEEK, AND CHIN, 1ML OF JUVÉDERM® VOLUX¿ WITH LIDOCAINE INTO THE CHIN, AND 0.4MLS OF JUVÉDERM® VOLBELLA¿ WITH LIDOCAINE INTO THE TEAR TROUGH. A LITTLE OVER A MONTH LATER, PATIENT EXPERIENCED MILD DENGUE, DEEMED NOT RELATED TO THE DEVICE. SYMPTOM RESOLVED THREE DAYS LATER WITHOUT TREATMENT. THIS IS THE SAME EVENT AND THE SAME PATIENT REPORTED UNDER MDR ID# 3005113652-2024-11035 (ABBVIE COMPLAINT #PR (B)(4)), MDR ID# 3005113652-2024-11034 (ABBVIE COMPLAINT #PR 2900003), MDR ID# 3005113652-2024-11029 (ABBVIE COMPLAINT #PR 2900004), MDR ID# 3005113652-2024-11031 (ABBVIE COMPLAINT #PR 2900006), MDR ID# 3005113652-2024-11032 (ABBVIE COMPLAINT #PR 2900007), MDR ID# 3005113652-2024-11033 (ABBVIE COMPLAINT #PR 2900008). THIS MDR IS BEING SUBMITTED FOR THE 4TH INJECTION OF SUSPECT PRODUCT, JUVÉDERM® VOLUX¿ WITH LIDOCAINE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    695293 UNK JUVEDERM VOLUX IMPLANT, DERMAL, FOR AESTHETIC USE LMH ALLERGAN (PRINGY) NI

    Patients

    Seq Age Sex Outcome Treatment
    1 57 YR Female Required Intervention LEVOTHYROXINE, OMEGA 3, TORSILAX.