BEUDAMED
    FDA Adverse Event Injury Summary report: N

    JUVEDERM VOLLURE XC 2X1 ML

    MDR report key: 10667267 · Received October 12, 2020

    Report

    Report Number
    3005113652-2020-00629
    Event Type
    Injury
    Date Received
    October 12, 2020
    Date of Event
    September 16, 2020
    Report Date
    December 17, 2020
    Manufacturer
    ALLERGAN (PRINGY)
    Product Code
    LMH
    UDI-DI
    10888628034471
    PMA / PMN Number
    P110033
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WY
    Reporter Occupation
    117

    Narratives

    Additional Manufacturer Narrative · 0

    A REVIEW OF THE DEVICE HISTORY RECORD HAS BEEN COMPLETED. NO DEVIATIONS OR NON-CONFORMANCES NOTED.

    Description of Event or Problem · 0

    ADDITIONAL INFORMATION: EVENT HAS RESOLVED.

    Description of Event or Problem · 0

    HEALTHCARE PROFESSIONAL REPORTED INJECTING A PATIENT WITH 1 ML OF JUVÉDERM VOLLURE¿ XC INTO THE NLF AREA. PATIENT RETURNED ABOUT 6 WEEKS LATER AND HAD ANOTHER 1ML SYRINGE OF JUVÉDERM VOLLURE¿ XC INTO LOWER FACE WRINKLES (RADIAL CHEEK LINES). PATIENT WAS SEEN ABOUT 4 WEEKS LATER AND WAS EXPERIENCING A SMALL LUMP ON THE NLF INJECTION SITE; IT IS NOT VISIBLE TO THE EYE, BUT IT IS PALPABLE. NLF AREA IS SLIGHTLY RED AND IRRITATED LOOKING. DOXY WAS PRESCRIBED FOR 7 DAYS AT 100MG 2X/DAY, AND THEN 20MG DOXY 2X/DAY FOR 14 DAYS AFTER. PATIENT IS STILL ON LOW DOSE DOXY, 0 ERYTHEMA, LOW NODULE. THIS IS THE SAME EVENT AND THE SAME PATIENT REPORTED UNDER MDR ID # 3005113652-2020-00628 (ALLERGAN COMPLAINT # (B)(4)). THIS MDR IS BEING SUBMITTED FOR THE SECOND SUSPECT PRODUCT, JUVÉDERM VOLLURE¿ XC, LOT V17LA90479.

    Additional Manufacturer Narrative · 1

    CLARIFICATION: THE FILLER WAS INJECTED INTO THE PATIENT AND IS NOT ACCESSIBLE FOR RETURN. THE SYRINGE WAS NOT RETURNED FOR EVALUATION. 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 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. FURTHER INFORMATION FROM THE REPORTER REGARDING EVENT, PRODUCT, OR PATIENT DETAILS HAS BEEN REQUESTED. NO ADDITIONAL INFORMATION IS AVAILABLE AT THIS TIME.

    Description of Event or Problem · 1

    HEALTHCARE PROFESSIONAL REPORTED INJECTING A PATIENT WITH 1 ML OF JUVÉDERM VOLLURE¿ XC INTO THE NLF AREA. PATIENT RETURNED ABOUT 6 WEEKS LATER AND HAD ANOTHER 1ML SYRINGE OF JUVÉDERM VOLLURE¿ XC INTO LOWER FACE WRINKLES (RADIAL CHEEK LINES). PATIENT WAS SEEN ABOUT 4 WEEKS LATER AND WAS EXPERIENCING A SMALL LUMP ON THE NLF INJECTION SITE; IT IS NOT VISIBLE TO THE EYE, BUT IT IS PALPABLE. NLF AREA IS SLIGHTLY RED AND IRRITATED LOOKING. DOXY WAS PRESCRIBED FOR 7 DAYS AT 100MG 2X/DAY, AND THEN 20MG DOXY 2X/DAY FOR 14 DAYS AFTER. PATIENT IS STILL ON LOW DOSE DOXY, 0 ERYTHEMA, LOW NODULE. THIS IS THE SAME EVENT AND THE SAME PATIENT REPORTED UNDER MDR ID # 3005113652-2020-00628 (ALLERGAN COMPLAINT # (B)(4)). THIS MDR IS BEING SUBMITTED FOR THE SECOND SUSPECT PRODUCT, JUVÉDERM VOLLURE¿ XC, LOT V17LA90479.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1130587 JUVEDERM VOLLURE XC 2X1 ML IMPLANT, DERMAL, FOR AESTHETIC USE LMH ALLERGAN (PRINGY) V17LA90479 10888628034471

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR Required Intervention