BEUDAMED
    FDA Adverse Event Injury Summary report: N

    JUVEDERM ULTRA XC 1 ML ROW

    MDR report key: 2994395 · Received March 5, 2013

    Report

    Report Number
    3005113652-2013-00019
    Event Type
    Injury
    Date Received
    March 5, 2013
    Date of Event
    February 1, 2013
    Report Date
    February 6, 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 03/05/2013. DEVICE LABELING: UNDESIRABLE EFFECTS: THE PTS 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, OCCURRING AFTER THE INJECTION. INDURATION OR NODULES AT THE INJECTION SITE. PTS 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. ANY OTHER UNDESIRABLE SIDE EFFECTS ASSOCIATED WITH INJECTION OF JUVEDERM ULTRA XC MUST BE REPORTED TO THE DISTRIBUTOR AND/OR TO THE MFR.

    Description of Event or Problem · 1

    HEALTHCARE PROFESSIONAL REPORTED THAT AFTER INJECTION IN THE GLABELLAR REGION WITH JUVEDERM ULTRA XC, THE PT EXPERIENCED SWELLING, REDNESS, A "LUMP AND TIGHTNESS" AT THE INJECTION SITE SIX MONTHS LATER. PT WAS TREATED WITH HYALURONIDASE AND WAS PRESCRIBED CIPROFLOXACIN. SYMPTOMS ARE ONGOING AT THIS TIME, YET ARE NOW "LESS FIRM AND LESS SWOLLEN."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    93998 JUVEDERM ULTRA XC 1 ML ROW LMH ALLERGAN NA H24L862178

    Patients

    Seq Age Sex Outcome Treatment
    1 46 YR Required Intervention LOSEC