BEUDAMED
    FDA Adverse Event Injury Summary report: N

    JUVEDERM (VOLUME/CONCENTRATION UNK)

    MDR report key: 3780660 · Received April 18, 2014

    Report

    Report Number
    3005113652-2014-00137
    Event Type
    Injury
    Date Received
    April 18, 2014
    Date of Event
    March 17, 2014
    Report Date
    March 21, 2014
    Manufacturer
    ALLERGAN
    Product Code
    LMH
    PMA / PMN Number
    O050047
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    ALLERGEN IS UNABLE TO CONFIRM WITH THE HEALTHCARE PROFESSIONAL, THEREFORE, ADD'L EVENT, PRODUCT, OR PATIENT DETAILS ARE NOT AVAILABLE. THE EVENTS OF "BIOFILM," "STAPH INFECTION," "MRSA," DERMAL FILLER "COMING OUT OF" THE PATIENT'S "PORES," AND PEELING SKIN ARE PHYSIOLOGICAL COMPLICATIONS AND ANALYSIS OF THE DEVICE GENERALLY DOES NOT ASSIST ALLERGAN IN DETERMINING A PROBABLE CAUSE FOR THIS EVENT.

    Description of Event or Problem · 1

    PATIENT REPORTED APPROX 5 MONTHS AFTER INJECTION WITH UNSPECIFIED JUVEDERM IN THE "LOWER JAW AREA" AND "NEAR" THE MARIONETTE LINES THEY DEVELOPED A POSSIBLE "BIOFILM," "STAPH INFECTION" AND "(B)(6)" AT THE INJECTION SITES. THE DERMAL FILLER WAS "COMING OUT" OF THE PATIENT'S "PORES" AND THE PATIENT'S "SKIN WAS PEELING." "ANTIBIOTICS" AND "STEROIDS" WERE PROVIDED AS TREATMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    238806 JUVEDERM (VOLUME/CONCENTRATION UNK) LMH LMH ALLERGAN NA NI

    Patients

    Seq Age Sex Outcome Treatment
    1 NI