BEUDAMED
    FDA Adverse Event Injury Summary report: N

    JUVEDERM ULTRA XC 1 ML ROW

    MDR report key: 9475556 · Received December 16, 2019

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    Report

    Report Number
    3005113652-2019-00876
    Event Type
    Injury
    Date Received
    December 16, 2019
    Report Date
    December 16, 2019
    Manufacturer
    ALLERGAN (PRINGY)
    Product Code
    LMH
    PMA / PMN Number
    P050047
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BR
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    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 COMPLETED. NO DEVIATIONS OR NON-CONFORMANCES NOTED. THIS IS A KNOWN POTENTIAL ADVERSE EVENT ADDRESSED IN THE PRODUCT LABELING.

    Description of Event or Problem · 1

    HEALTHCARE PROFESSIONAL REPORTS THAT A PATIENT WAS INJECTED WITH JUVÉDERM ULTRA¿ XC AND EXPERIENCED EDEMA, ERYTHEMA AND HARDENING OF THE TREATED AREAS APPROXIMATELY 30-45 DAYS AFTER THE APPLICATION. THE PHYSICIAN EXAMINED THE PATIENT AND DID NOT IDENTIFY COLLECTIONS FOR DRAINAGE. THE PHYSICIAN DID NOT PERFORM FURTHER EXAMS. THE PHYSICIAN HYPOTHESIZED BIOFILM AND ASSOCIATED IT WITH THE JUVÉDERM ULTRA¿ XC INJECTION. PHYSICIAN STARTED TREATMENT WITH PREDSIM, CLARITHROMYCIN + CIPROFLOXACIN FOR 20 TO 40 DAYS AND INJECTED HYALURONIDASE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1271412 JUVEDERM ULTRA XC 1 ML ROW IMPLANT, DERMAL, FOR AESTHETIC USE LMH ALLERGAN (PRINGY) H24LA80219

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention