BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SKINVIVE BY JUVEDERM XC 2X1 ML

    MDR report key: 18564917 · Received January 23, 2024

    Report

    Report Number
    9617229-2024-01277
    Event Type
    Injury
    Date Received
    January 23, 2024
    Date of Event
    November 26, 2013
    Report Date
    April 15, 2024
    Manufacturer
    ALLERGAN (PRINGY)
    Product Code
    LMH
    UDI-DI
    10840228300066
    PMA / PMN Number
    P110033
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    117

    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. THE EVENT OF INFECTION-NDR, DEEMED NOT DEVICE RELATED IS CONSIDERED AN UNEXPECTED ADVERSE DRUG EXPERIENCE.

    Additional Manufacturer Narrative · 0

    ADDITIONAL, CORRECTED, AND/OR CHANGED DATA.

    Description of Event or Problem · 0

    HEALTHCARE PROFESSIONAL REPORTED THAT A PATIENT WAS INJECTED IN THE CHEEKS WITH 2 ML OF SKINVIVE¿ BY JUVÉDERM®. EARLY THE NEXT MONTH, THE PATIENT CONTRACTED NON-DEVICE RELATED ¿COVID-19¿ THEN NON-DEVICE RELATED ¿SINUSITIS¿ AND ¿SUBSEQUENT AUTOIMMUNE RESPONSE TO SKINVIVE¿ BY JUVÉDERM®.¿ LATER IN THE MONTH, THE PATIENT EXPERIENCED ¿NODULES¿ AND ¿SWELLING¿ AT THE INJECTION SITE. TWO AND A HALF WEEKS LATER, THE PATIENT WAS TREATED WITH HYLENEX, WITH SOME RESOLUTION. FIVE DAYS LATER, THE PATIENT WAS TREATED WITH HYLENEX AND PREDNISONE X 14 DAYS. THE NODULES THEN REOCCURRED AND THE PATIENT WAS TREATED WITH KEFLEX X 10 DAYS A WEEK AFTER THE FIRST TREATMENT. TWO DAYS LATER, THE PATIENT WAS TREATED WITH HYLENEX AND A 10-DAY DOSE OF KEFLEX. THE NODULES WERE NOTED AS ¿MODERATELY ERYTHEMATOUS, TENDER, AND INFLAMED.¿ HALF A MONTH LATER, THE PATIENT HAD A PUNCH BIOPSY AND BACTERIAL CULTURE THAT CAME BACK AS NEGATIVE. THE EVENT IS ONGOING. THIS IS THE SAME EVENT AND THE SAME PATIENT REPORTED UNDER EMDR-17404. THIS EMDR IS BEING SUBMITTED FOR THE SERIOUS UNEXPECTED ADVERSE DRUG EXPERIENCE. THIS IS THE SAME EVENT AND THE SAME PATIENT REPORTED UNDER PATIENT IDENTIFIER CN-061454 (EMDR-17760). THIS EMDR IS BEING SUBMITTED FOR INITIAL EVENT ONSET.

    Description of Event or Problem · 0

    HEALTHCARE PROFESSIONAL REPORTED THAT THE EVENT RESOLVED 3 MONTHS POST-ONSET.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    799646 SKINVIVE BY JUVEDERM XC 2X1 ML IMPLANT, DERMAL, FOR AESTHETIC USE LMH ALLERGAN (PRINGY) NI 10840228300066

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Female Required Intervention