BEUDAMED
    FDA Adverse Event Injury Summary report: N

    JUVEDERM VOLUMA WITH LIDOCAINE 1ML

    MDR report key: 15486184 · Received September 26, 2022

    Report

    Report Number
    3005113652-2022-00617
    Event Type
    Injury
    Date Received
    September 26, 2022
    Date of Event
    July 18, 2022
    Report Date
    October 14, 2022
    Manufacturer
    ALLERGAN (PRINGY)
    Product Code
    LMH
    PMA / PMN Number
    P110033
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    CLARIFICATION: 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. THE EVENT OF TACHYCARDIA, DEEMED NOT DEVICE RELATED IS CONSIDERED AN UNEXPECTED ADVERSE DRUG EXPERIENCE.

    Additional Manufacturer Narrative · 0

    A REVIEW OF THE DEVICE HISTORY RECORD HAS BEEN COMPLETED. NO DEVIATIONS OR NON-CONFORMANCES NOTED. ADDITIONAL, CHANGED, AND/OR CORRECTED DATA: H.6.

    Description of Event or Problem · 0

    HEALTHCARE PROFESSIONAL REPORTED ¿PATIENT IS GETTING SWELLING EVERY WEEK ON ALL THE PARTS WHERE FILLER WAS INJECTED¿ SIX DAYS AFTER THEY WERE INJECTED IN CK1 AND 2, JW 1, 2 AND 3, AND C1 WITH TWO SYRINGES OF JUVÉDERM® VOLUMA¿ WITH LIDOCAINE. PATIENT WAS TREATED WITH STEROIDS JUST AFTER PROCEDURE BUT HAS TO STOPPED THE TREATMENT DUE TO TACHYCARDIA, DEEMED NOT RELATED TO THE DEVICE. AT SOME POINTS, SWELLING REDUCES THERE BUT AGAIN IN A WEEK'S TIME ANTHER POINT SWELLS UP. PATIENT WAS TREATED WITH "HYALASED THE AREAS ALMOST 6-7 TIMES WITH IMPROVEMENT AFTER EACH SESSION OF HYALASE.¿ EVENT IS ONGOING AT THIS TIME.

    Description of Event or Problem · 0

    HEALTHCARE PROFESSIONAL REPORTED ¿PATIENT IS GETTING SWELLING EVERY WEEK ON ALL THE PARTS WHERE FILLER WAS INJECTED¿ SIX DAYS AFTER THEY WERE INJECTED IN CK1 AND 2, JW 1, 2 AND 3, AND C1 WITH TWO SYRINGES OF JUVÉDERM® VOLUMA¿ WITH LIDOCAINE. PATIENT WAS TREATED WITH STEROIDS JUST AFTER PROCEDURE BUT HAS TO STOPPED THE TREATMENT DUE TO TACHYCARDIA, DEEMED NOT RELATED TO THE DEVICE. AT SOME POINTS, SWELLING REDUCES THERE BUT AGAIN IN A WEEK'S TIME ANTHER POINT SWELLS UP. PATIENT WAS TREATED WITH "HYALASED THE AREAS ALMOST 6-7 TIMES WITH IMPROVEMENT AFTER EACH SESSION OF HYALASE.¿ EVENT IS ONGOING AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2935404 JUVEDERM VOLUMA WITH LIDOCAINE 1ML IMPLANT, DERMAL, FOR AESTHETIC USE LMH ALLERGAN (PRINGY) VB20B10954

    Patients

    Seq Age Sex Outcome Treatment
    1 48 YR Female