BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNK JUVEDERM VOLUX

    MDR report key: 20685697 · Received November 14, 2024

    Report

    Report Number
    3005113652-2024-00730
    Event Type
    Injury
    Date Received
    November 14, 2024
    Date of Event
    November 4, 2024
    Report Date
    November 14, 2024
    Manufacturer
    PRINGY
    Product Code
    LMH
    PMA / PMN Number
    P110033
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    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", DEEMED NOT DEVICE RELATED IS CONSIDERED AN UNEXPECTED ADVERSE DRUG EXPERIENCE.

    Description of Event or Problem · 0

    HEALTHCARE PROFESSIONAL (HCP) REPORTED THAT A PATIENT WAS INJECTED IN THE AREA OF CK3 APPROXIMATELY (0.5ML), IN THE CORNER OF THE MOUTH (0.2ML), IN CK5 (0.2ML), POINTED IN THE CHIN (0.2ML) WITH [UNSPECIFIED] JUVÉDERM® VOLUMA¿ AND IN JW1 (0.2ML) PER SIDE, INTO THE JAWLINE (0.3ML) WITH JUVÉDERM® VOLUX¿ AND ONE MONTH AFTER PRESENTED AGAIN AND INJECTED WITH [UNSPECIFIED] JUVÉDERM® VOLUMA¿ IN CK1 (3X0.1 ML), CHIN CENTER (0.1ML) AND BELOW CK3 ON THE LEFT (0.3ML) WHERE THERE WAS ALREADY A ¿HOLE¿. WHILE ON VACATION, PATIENT EXPERIENCED "REDDENING AND SCALING APPEARED IN BOTH NASOLABIAL FOLDS (BUT THESE WERE NOT TREATED WITH FILLERS)". PATIENT WAS TREATED WITH CEPHALEXIN 1000 2XTGL INITIATED PRIMARILY DUE TO A NON-DEVICE RELATED INFECTION. AS A RESULT, THE SYMPTOMS IMPROVED AND WERE THEN HEALED TO A DISCREET RESIDUAL REDNESS. APPROXIMATELY, IN ABOUT FOUR MONTHS AFTER THE TREATMENT PROVIDED PATIENT PRESENTED AGAIN CONTINUED TO HAVE COMPLAINTS SINCE THEN, "ESPECIALLY IN THE AREA OF THE CHIN AND CHEEK REGION". ACCORDING TO THE PATIENT, THIS REGION IS SWOLLEN AND ¿PIMPLES¿ FORM AGAIN AND AGAIN, FROM WHICH A CLEAR LIQUID EMPTIES OUT UNDER PRESSURE (WAS ALSO ABLE TO DEMONSTRATE THIS ON THE DAY OF THE VISIT). AS A RESULT OF THIS EMPTYING OF THE LIQUID, IT "NOW HAS VARIOUS EROSIONS IN THE CHIN AND MOUTH AREA". IN ADDITION, THERE IS STILL A NOTICEABLE DENT IN THE AREA OF CK 3 LEFT WHICH, ACCORDING TO PATIENT, ONLY DEVELOPED OVER TIME AFTER TREATMENT AND WAS NOT SO PRONOUNCED BEFORE. APART FROM THE ABOVE MENTIONED ANTIBIOSIS, THE PATIENT HAS HAD NO FURTHER TREATMENT SO FAR, INCLUDING HYLASE". THIS IS THE SAME EVENT AND THE SAME PATIENT REPORTED UNDER PATIENT IDENTIFIER CN-162376 (EMDR-58747), CN-162381 (EMDR-58707), CN-162377 (EMDR-58750), CN-162383 (EMDR-58729), AND CN-162375 (EMDR-58737). THIS EMDR IS BEING SUBMITTED FOR THE SUSPECT PRODUCT, SECOND OCCURRENCE OF EVENTS AFTER THEY HAD INITIALLY RESOLVED WITH JUVÉDERM® VOLUX¿.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1195614 UNK JUVEDERM VOLUX IMPLANT, DERMAL, FOR AESTHETIC USE LMH PRINGY NI

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Female Required Intervention