BEUDAMED
    FDA Adverse Event Injury Summary report: N

    JUVEDERM ULTRA XC/LIDO (VOLUME UNKNOWN)

    MDR report key: 3221488 · Received July 9, 2013

    Report

    Report Number
    3005113652-2013-00088
    Event Type
    Injury
    Date Received
    July 9, 2013
    Date of Event
    June 10, 2013
    Report Date
    June 12, 2013
    Manufacturer
    ALLERGAN
    Product Code
    LMH
    PMA / PMN Number
    P050047
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    MEDWATCH SENT TO FDA ON (B)(4) 2013. ATTEMPTS TO FOLLOW UP WITH THE INJECTING HEALTHCARE PROFESSIONAL HAVE BEEN UNSUCCESSFUL; DEVICE LOT NUMBER IS UNAVAILABLE AT THIS TIME. DEVICE LABELING: PRECAUTIONS FOR USE. AS A MATTER OF GENERAL PRINCIPLE, INJECTION OF A MEDICAL DEVICE IS ASSOCIATED WITH A RISK OF INFECTION. UNDESIRABLE EFFECTS: THE PATIENTS MUST BE INFORMED THAT THEY ARE POTENTIAL SIDE EFFECTS ASSOCIATED WITH IMPLANTATION OF THIS PRODUCT, WHICH MAY OCCUR IMMEDIATELY OR MAY BE DELAYED. THESE INCLUDE, BUT ARE NOT LIMITED TO: INFLAMMATORY REACTIONS (REDNESS, OEDEMA, ERYTHEMA, ETC.) WHICH MAY BE ASSOCIATED WITH ITCHING OR PAIN ON PRESSURE OR BOTH, OCCURING AFTER THE INJECTION. INDURATION OR NODULES AT THE INJECTION SITE. PATIENT MUST REPORT INFLAMMATORY REACTIONS WHICH PERSIST FOR MORE THAN ONE WEEK OR ANY OTHER SECONDARY EFFECT WHICH DEVELOPS, TO THEIR MEDICAL PRACTITIONER AS SOON AS POSSIBLE. THE MEDICAL PRACTITIONER SHOULD USE AN APPROPRIATE TREATMENT.

    Description of Event or Problem · 1

    PHYSICIAN REPORTED AFTER INJECTION WITH JUVEDERM ULTRA XC IN THE NASOLABIAL FOLDS WITH AND JUVEDERM VOLUMA WITH LIDOCAINE IN THE CHEEKS, PATIENT DEVELOPED "PAIN, WARMTH, SWELLING REDNESS" AND "INFECTION" 5 DAYS AFTER INJECTION. PATIENT WAS TREATED WITH ICE, "DURICEF", AND "VOLTAREN." PATIENT DEVELOPED A VAGUE LUMP 5 DAYS AFTER TREATMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    312689 JUVEDERM ULTRA XC/LIDO (VOLUME UNKNOWN) LMH ALLERGAN NA NI

    Patients

    Seq Age Sex Outcome Treatment
    1 41 YR Required Intervention CHEEKS| JUVEDERM VOLUMA WITH LIDOCAINE INJECTION TO THE