BEUDAMED
    FDA Adverse Event Death Summary report: N

    SKINVIVE BY JUVEDERM XC 2X1 ML

    MDR report key: 18361081 · Received December 19, 2023

    Report

    Report Number
    3005113652-2023-10055
    Event Type
    Death
    Date Received
    December 19, 2023
    Date of Event
    December 7, 2023
    Report Date
    December 19, 2023
    Manufacturer
    PRINGY
    Product Code
    LMH
    PMA / PMN Number
    P110033
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, 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. THE EVENT IS A PHYSIOLOGICAL COMPLICATION AND ANALYSIS OF THE DEVICE GENERALLY DOES NOT ASSIST ABBVIE IN DETERMINING A PROBABLE CAUSE FOR THIS EVENT. FURTHER INFORMATION REGARDING EVENT, PRODUCT, OR PATIENT DETAILS HAS BEEN REQUESTED. NO ADDITIONAL INFORMATION IS AVAILABLE AT THIS TIME. 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. THE EVENT OF DEATH, DEEMED NOT DEVICE RELATED IS CONSIDERED AN UNEXPECTED ADVERSE DRUG EXPERIENCE.

    Description of Event or Problem · 0

    HEALTHCARE PROFESSIONAL REPORTED A PATIENT WAS INJECTED WITH 2MLS OF SKINVIVE¿ BY JUVÉDERM® INTO THE CHEEKS (1ML ON EACH SIDE). THERE WERE NO ISSUES WITH THE INJECTION. THE NEXT DAY, PATIENT PASS AWAY, DEEMED NOT DEVICE RELATED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2205406 SKINVIVE BY JUVEDERM XC 2X1 ML IMPLANT, DERMAL, FOR AESTHETIC USE LMH PRINGY 1000524571

    Patients

    Seq Age Sex Outcome Treatment
    1 69 YR Female Death FIORNIAL.| OXYCODONE.| SYNTHROID.