BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SKINVIVE BY JUVEDERM XC 2X1 ML

    MDR report key: 19273876 · Received May 8, 2024

    Report

    Report Number
    3005113652-2024-00301
    Event Type
    Injury
    Date Received
    May 8, 2024
    Date of Event
    March 22, 2024
    Report Date
    May 8, 2024
    Manufacturer
    ALLERGAN (PRINGY)
    Product Code
    LMH
    PMA / PMN Number
    P110033
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    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. THIS IS A KNOWN POTENTIAL ADVERSE EVENT ADDRESSED IN THE PRODUCT LABELING. 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.

    Description of Event or Problem · 0

    HEALTHCARE PROFESSIONAL REPORTED THAT A PATIENT WAS INJECTED WITH 2ML OF SKINVIVE¿ BY JUVÉDERM® IN THE CHEEKS. THREE MONTHS LATER, THE PATIENT WAS INJECTED AGAIN WITH 2 ML OF SKINVIVE¿ BY JUVÉDERM® IN THE CHEEKS . IMMEDIATELY, THE PATIENT EXPERIENCED ¿BUMPS¿ THAT BECAME ¿RED AND INFLAMED.¿ THIS CONTINUED WITH MINIMAL IMPROVEMENT AFTER A MASSAGE WITH A Q-TIP. SOME OF THE REACTION WAS ATTRIBUTED TO PRODUCT PLACEMENTS AND SOME WAS ATTRIBUTED TO FROM AN INFLAMMATORY RESPONSE, WHERE BOTH CHEEKS BECAME ¿PINK AND MORE BUMPY.¿ THE DAY AFTER THE LATER INJECTION, THE PATIENT WAS TREATED WITH ZYRTEC. FOUR WEEKS LATER, SYMPTOMS HAS BEEN RESOLVED. THIS IS THE SAME EVENT AND THE SAME PATIENT REPORTED UNDER ABBVIE COMPLAINT CN-081142(EMDR-147159). THIS EMDR IS BEING SUBMITTED FOR THE FIRST SUSPECT PRODUCT, SKINVIVE BY JUVEDERM XC.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    99140 SKINVIVE BY JUVEDERM XC 2X1 ML IMPLANT, DERMAL, FOR AESTHETIC USE LMH ALLERGAN (PRINGY) 1000524571

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR Female Required Intervention