BEUDAMED
    FDA Adverse Event Injury Summary report: N

    JUVEDERM VOLUMA XC/LIDO (VOLUME UNKNOWN)

    MDR report key: 18471460 · Received January 8, 2024

    Report

    Report Number
    3005113652-2024-10003
    Event Type
    Injury
    Date Received
    January 8, 2024
    Date of Event
    October 24, 2023
    Report Date
    January 8, 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

    CONTINUED H.6. HEALTH EFFECT - IMPACT CODES: F22. 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 RHABDOMYOLYSIS, DEEMED NOT DEVICE RELATED IS CONSIDERED AN UNEXPECTED ADVERSE DRUG EXPERIENCE.

    Description of Event or Problem · 0

    HEALTHCARE PROFESSIONAL REPORTED A CLINICAL STUDY PATIENT WAS INJECTED WITH 5MLS OF HARMONYCA WITH LIDOCAINE IN THE ZYGOMATIC, MALAR, AND MANDIBULAR. A MONTH LATER, PATIENT WAS INJECTED WITH 2MLS OF JUVÉDERM® VOLUX¿ INTO THE MANDIBLE, JAWLINE, AND CHIN; 2.4MLS OF JUVÉDERM® VOLUMA¿ WITH LIDOCAINE INTO THE CHEEK AND ZYGOMATIC; AND 1.4MLS JUVÉDERM® VOLIFT® WITH LIDOCAINE INTO THE NASOLABIAL AND PERIORAL AREAS. THREE AND A HALF WEEKS LATER, PATIENT BEGAN TO FEEL "VERY TIRED, BUT WITHOUT ANY LOCALIZED PAIN. THEY THOUGH THEY GOT A FLU, BUT SINCE THEIR SYMPTOMS DID NOT IMPROVE THEY DECIDED TO GO TO HOSPITAL. WHEN THERE, THEY WERE SUBMITTED TO BLOOD TESTS THAT FOUND HIGH SERUM TOTAL CREATINE PHOSPHOKINASE LEVELS. PATIENT EXPERIENCED RHABDOMYOLYSIS, DEEMED NOT DEVICE RELATED. PATIENT WAS HOSPITALIZED AND WAS TREATED WITH IV SALINE SOLUTION FOR 48 HOURS. PATIENT DISCHARGED TWO DAYS LATER AND EVENT RESOLVED. THIS IS THE SAME EVENT AND THE SAME PATIENT REPORTED UNDER MDR ID# 3005113652-2023-00930 (ABBVIE COMPLAINT #(B)(4) ), MDR ID# 3005113652-2024-10002 (ABBVIE COMPLAINT #(B(4) ), MDR ID# 3005113652-2024-10004 (ABBVIE COMPLAINT #PR 2892697). 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
    597945 JUVEDERM VOLUMA XC/LIDO (VOLUME UNKNOWN) IMPLANT, DERMAL, FOR AESTHETIC USE LMH ALLERGAN (PRINGY) NI

    Patients

    Seq Age Sex Outcome Treatment
    1 38 YR Male Required Intervention| H JUVÉDERM® VOLIFT® WITH LIDOCAINE, JUVÉDERM® VOLUX¿