BEUDAMED
    FDA Adverse Event Injury Summary report: N

    JUVEDERM VOLUMA WITH LIDOCAINE

    MDR report key: 12336452 · Received August 18, 2021

    Report

    Report Number
    3005113652-2021-03132
    Event Type
    Injury
    Date Received
    August 18, 2021
    Date of Event
    July 15, 2021
    Report Date
    December 13, 2021
    Manufacturer
    ALLERGAN (PRINGY)
    Product Code
    LMH
    PMA / PMN Number
    P110033
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AR
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

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

    Additional Manufacturer Narrative · 0

    ADDITIONAL, CHANGED, AND/OR CORRECTED DATA: B.5., H.6.

    Description of Event or Problem · 0

    HEALTHCARE PROFESSIONAL REPORTED THAT PATIENT WAS INJECTED WITH JUVÉDERM® VOLUMA¿ WITH LIDOCAINE IN THE NASAL DORSUM FOR A RHINOMODELING. SIX HOURS LATER, PATIENT THOUGHT THERE WAS A HEMATOMA AND AN AREA OF TISSUE DISTRESS WAS OBSERVED WITH AREAS OF CYANOSIS AND PUSTULES. TWO DAYS LATER, PATIENT WAS TREATED WITH HYALURONIDASE 1500U. ONE DAY LATER, PATIENT WAS TREATED AGAIN WITH 1500U HYALURONIDASE. PATIENT WAS ALSO TREATED WITH PREDNIDONE 20 MG DAY X DAY, AAS 325 EVERY 12 HS X 7 DAYS, TADALAFIL 20 MG DAY X 3 DAYS, AND LOCAL TREATMENT WITH MASSAGES AND HOT PACKS.

    Description of Event or Problem · 0

    FURTHER INFORMATION REPORTED SYMPTOMS RESOLVED.

    Additional Manufacturer Narrative · 1

    FURTHER INFORMATION FROM THE REPORTER REGARDING EVENT, PRODUCT, OR PATIENT DETAILS HAS BEEN REQUESTED. NO ADDITIONAL INFORMATION IS AVAILABLE AT THIS TIME. THE EVENTS ARE PHYSIOLOGICAL COMPLICATIONS AND ANALYSIS OF THE DEVICE GENERALLY DOES NOT ASSIST ALLERGAN IN DETERMINING A PROBABLE CAUSE FOR THESE EVENTS. CLARIFICATION: THE FILLER WAS INJECTED INTO THE PATIENT AND IS NOT ACCESSIBLE FOR RETURN. THE SYRINGE WAS NOT RETURNED FOR EVALUATION. 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.

    Description of Event or Problem · 1

    HEALTHCARE PROFESSIONAL REPORTED THAT PATIENT WAS INJECTED WITH JUVÉDERM® VOLUMA¿ WITH LIDOCAINE IN THE NASAL DORSUM FOR A RHINOMODELING. SIX HOURS LATER, PATIENT THOUGHT THERE WAS A HEMATOMA AND AN AREA OF TISSUE DISTRESS WAS OBSERVED WITH AREAS OF CYANOSIS AND PUSTULES. TWO DAYS LATER, PATIENT WAS TREATED WITH HYALURONIDASE 1500U. ONE DAY LATER, PATIENT WAS TREATED AGAIN WITH 1500U HYALURONIDASE. PATIENT WAS ALSO TREATED WITH PREDNIDONE 20 MG DAY X DAY, AAS 325 EVERY 12 HS X 7 DAYS, TADALAFIL 20 MG DAY X 3 DAYS, AND LOCAL TREATMENT WITH MASSAGES AND HOT PACKS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1236186 JUVEDERM VOLUMA WITH LIDOCAINE IMPLANT, DERMAL, FOR AESTHETIC USE LMH ALLERGAN (PRINGY) VB20B00656

    Patients

    Seq Age Sex Outcome Treatment
    1 Female Required Intervention| O