BEUDAMED
    FDA Adverse Event Injury Summary report: N

    JUVEDERM ULTRA PLUS XC TSK US

    MDR report key: 21314486 · Received February 5, 2025

    Report

    Report Number
    3005113652-2025-00107
    Event Type
    Injury
    Date Received
    February 5, 2025
    Date of Event
    December 20, 2023
    Report Date
    February 18, 2025
    Manufacturer
    PRINGY
    Product Code
    LMH
    PMA / PMN Number
    P050047
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    THIS IS IN RESPONSE TO MEDWATCH MW5165162.

    Additional Manufacturer Narrative · 0

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

    Description of Event or Problem · 0

    ADDITIONALLY, THE HEALTHCARE PROFESSIONAL REPORTED INJECTING THE PATIENT IN THE CHEEKS WITH 1 SYRINGE OF JUVÉDERM® VOLUMA¿ XC. SEVEN MONTHS LATER, THE PATIENT WAS INJECTED IN THE LIPS WITH 1 SYRINGE OF JUVÉDERM® ULTRA PLUS XC. THE HEALTHCARE PROFESSIONAL REPORTED NEVER INJECTING THE PATIENT IN THE NOSE OR PENILE GLAND. THE PATIENT RETURNED 6 MONTHS LATER, ASKING TO DISSOLVE FILLER ON THE NOSE BUT COULD NOT CONFIRM WHAT WAS INJECTED THERE. THE PATIENT WAS MADE AWARE THAT THEY DID NOT NEED DISSOLVER BUT INSISTED. THE HEALTHCARE PROFESSIONAL WENT OVER THE PATIENT¿S PAST CARE. NO MEDICATIONS OR TREATMENTS WERE GIVEN. EVENT STATUS IS UNKNOWN.

    Description of Event or Problem · 0

    PATIENT REPORTED BEING INJECTED WITH JUVÉDERM® VOLUMA¿ XC AND AN UNSPECIFIED JUVÉDERM®. THE PATIENT ALSO REPORTED BEING INJECTED IN THE NOSE AND PENILE GLAND WITH AN UNSPECIFIED DERMAL FILLER. THE PATIENT DEVELOPED ¿BREATHING ISSUES, DIARRHEA, SWELLING, JOINT STIFFNESS, ARTHRITIC SYMPTOMS, NAUSEA, FATIGUE, TINNITUS,¿ AND ¿DEVICE MIGRATION¿ THE PATIENT REPORTED THAT THE NOSE INJECTION RESULTED IN AN ¿ABSCESS,¿ CAUSING ¿TISSUE CRACKING¿ AND THE RIGHT-SIDE CHEEK ¿SWELLING.¿ THE PATIENT STARTED ¿MEDICAL CASE, SURGERY, AND PRE-CANCER SURGERY REMOVAL.¿ THE PATIENT HAS BEEN TREATED WITH HYLENEX, HEAVY CREAM ANTIBIOTICS AND ORAL ANTIBIOTICS. A CAT SCAN AND MRI WERE PERFORMED, BUT THE RESULTS WERE NOT SHARED. EVENTS ARE ONGOING. THIS IS THE SAME EVENT AND THE SAME PATIENT REPORTED UNDER PATIENT IDENTIFIER (B)(4). THIS EMDR IS BEING SUBMITTED FOR UNSPECIFIED JUVÉDERM®. REGULATORY AGENCY RECEIVED THE FOLLOWING REPORT FROM A PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    63774 JUVEDERM ULTRA PLUS XC TSK US IMPLANT, DERMAL, FOR AESTHETIC USE LMH PRINGY 1000542774

    Patients

    Seq Age Sex Outcome Treatment
    1 52 YR Male Required Intervention