BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SKINVIVE BY JUVEDERM XC 2X1 ML

    MDR report key: 18097110 · Received November 8, 2023

    Report

    Report Number
    3005113652-2023-00883
    Event Type
    Injury
    Date Received
    November 8, 2023
    Date of Event
    October 28, 2023
    Report Date
    December 4, 2023
    Manufacturer
    ALLERGAN (PRINGY)
    Product Code
    LMH
    UDI-DI
    10840228300066
    PMA / PMN Number
    P110033
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    PHYSICIAN ASSISTANT
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    CORRECTED DATA: H6.

    Additional Manufacturer Narrative · 0

    CLARIFICATION TO SECTION C. SUSPECT PRODUCT: LOT NUMBER 963/3. CONTINUED H.6. TYPE OF INVESTIGATION CODE: B15, B17, B20. 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 REPORTING THAT PATIENT WAS INJECTED WITH 2 SYRINGES OF SKINVIVE¿ BY JUVÉDERM IN THE CHEEKS. TWO DAYS LATER, THE PATIENT EXPERIENCED A ¿VASCULAR OCCLUSION¿. PATIENT WAS TREATED WITH HYLENEX, ASPIRIN 81 MG, A MEDRO DOSEPAK, MUPIROCIN 2% TOPICAL OINTMENT, AND NITROGLYCERIN PASTE. TWO DAYS LATER, SYMPTOMS HAS BEEN RESOLVED.

    Description of Event or Problem · 0

    HEALTHCARE PROFESSIONAL REPORTING THAT PATIENT WAS INJECTED WITH 2 SYRINGES OF SKINVIVE¿ BY JUVÉDERM IN THE CHEEKS. TWO DAYS LATER, THE PATIENT EXPERIENCED A ¿VASCULAR OCCLUSION¿. PATIENT WAS TREATED WITH HYLENEX, ASPIRIN 81 MG, A MEDRO DOSEPAK, MUPIROCIN 2% TOPICAL OINTMENT, AND NITROGLYCERIN PASTE. TWO DAYS LATER, SYMPTOMS HAS BEEN RESOLVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1524319 SKINVIVE BY JUVEDERM XC 2X1 ML IMPLANT, DERMAL, FOR AESTHETIC USE LMH ALLERGAN (PRINGY) 1000527726 10840228300066

    Patients

    Seq Age Sex Outcome Treatment
    1 47 YR Female Required Intervention| O