BEUDAMED
    FDA Adverse Event Injury Summary report: N

    JUVEDERM VOLBELLA XC 2 X 1ML 32G

    MDR report key: 21893035 · Received April 23, 2025

    Report

    Report Number
    3005113652-2025-00393
    Event Type
    Injury
    Date Received
    April 23, 2025
    Date of Event
    March 3, 2025
    Report Date
    April 29, 2025
    Manufacturer
    PRINGY
    Product Code
    LMH
    UDI-DI
    10888628043541
    PMA / PMN Number
    P110033
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CT, 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. 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. THIS IS A KNOWN POTENTIAL ADVERSE EVENT ADDRESSED IN THE PRODUCT LABELING.

    Additional Manufacturer Narrative · 0

    ADDITIONAL, CORRECTED, AND/OR CHANGED DATA: H6.

    Description of Event or Problem · 0

    HEALTHCARE PROFESSIONAL HCP REPORTED INJECTING A PATIENT IN THE LIPS WITH 0.4ML OF JUVÉDERM® VOLBELLA® XC. TWENTY DAYS LATER, HCP REUSED THE SYRINGE AND INJECTED THE PATIENT WITH 0.6ML OF JUVÉDERM® VOLBELLA® XC IN THE LIPS. PATIENT BEGAN TO EXPERIENCE "VERY DELAYED NODULES" ABOUT 4 OR 5 MONTHS POST INJECTION. HCP LATER REPORTED THE PATIENT WAS PRESCRIBED VALTREX 1G BID X 7 DAYS FOR PRESENCE OF [NOT DEVICE RELATED] COLD SORE AND MEDROL DOSE PACK FOR INFLAMMATION THE SAME DAY AS SYMPTOM ONSET. ELEVEN DAYS LATER, HCP INJECTED THE PATIENT WITH HYALURONIDASE 50U. THREE DAYS LATER HCP INJECTED THE PATIENT WITH HYALURONIDASE 65U. SEVEN DAYS LATER, HCP INJECTED THE PATIENT WITH HYALURONIDASE 90U. PRESCRIBED THE PATIENT VALTREX 1G BID X 7 DAYS FOR THE [NOT DEVICE RELATED] COLD SORE. SEVEN DAYS LATER, HCP INJECTED THE PATIENT WITH HYALURONIDASE 100U. PATIENT AGREED TO START TAKING PREDNISONE 30 MG X 3 DAYS, 20 MG X 2 DAYS, 10 MG X 2 DAYS. PATIENT DECLINED FURTHER TREATMENT, PREFERRING TO "ALLOW [THEIR] BODY TO NATURALLY METABOLIZE". SYMPTOMS ARE ONGOING. THE PRODUCT WAS TRANSFERRED TO A TB SYRINGE PRIOR TO INJECTION. THIS IS THE SAME EVENT AND THE SAME PATIENT REPORTED UNDER PATIENT IDENTIFIER (B)(6). THIS EMDR IS BEING SUBMITTED FOR THE SUSPECT PRODUCT, INITIAL INJECTION IN THE LIPS WITH 0.4ML OF JUVÉDERM® VOLBELLA® XC.

    Description of Event or Problem · 0

    HEALTHCARE PROFESSIONAL HCP REPORTED INJECTING A PATIENT IN THE LIPS WITH 0.4ML OF JUVÉDERM® VOLBELLA® XC. TWENTY DAYS LATER, HCP REUSED THE SYRINGE AND INJECTED THE PATIENT WITH 0.6ML OF JUVÉDERM® VOLBELLA® XC IN THE LIPS. PATIENT BEGAN TO EXPERIENCE "VERY DELAYED NODULES" ABOUT 4- OR 5-MONTHS POST INJECTION. HCP LATER REPORTED THE PATIENT WAS PRESCRIBED VALTREX 1G BID X 7 DAYS FOR PRESENCE OF [NOT DEVICE RELATED] COLD SORE AND MEDROL DOSE PACK FOR INFLAMMATION THE SAME DAY AS SYMPTOM ONSET. ELEVEN DAYS LATER HCP INJECTED THE PATIENT WITH HYALURONIDASE 50U. THREE DAYS LATER HCP INJECTED THE PATIENT WITH HYALURONIDASE 65U. SEVEN DAYS LATER, HCP INJECTED THE PATIENT WITH HYALURONIDASE 90U. PRESCRIBED THE PATIENT VALTREX 1G BID X 7 DAYS FOR THE [NOT DEVICE RELATED] COLD SORE. SEVEN DAYS LATER, HCP INJECTED THE PATIENT WITH HYALURONIDASE 100U. PATIENT AGREED TO START TAKING PREDNISONE 30 MG X 3 DAYS, 20 MG X 2 DAYS, 10 MG X 2 DAYS. PATIENT DECLINED FURTHER TREATMENT, PREFERRING TO "ALLOW [THEIR] BODY TO NATURALLY METABOLIZE". SYMPTOMS ARE ONGOING. THE PRODUCT WAS TRANSFERRED TO A TB SYRINGE PRIOR TO INJECTION. THIS IS THE SAME EVENT AND THE SAME PATIENT REPORTED UNDER PATIENT IDENTIFIER (B)(6). THIS EMDR IS BEING SUBMITTED FOR THE SUSPECT PRODUCT, INITIAL INJECTION IN THE LIPS WITH 0.4ML OF JUVÉDERM® VOLBELLA® XC.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1257382 JUVEDERM VOLBELLA XC 2 X 1ML 32G IMPLANT, DERMAL, FOR AESTHETIC USE LMH PRINGY 1000600429 10888628043541

    Patients

    Seq Age Sex Outcome Treatment
    1 50 YR Female Required Intervention