BEUDAMED
    FDA Adverse Event Injury Summary report: N

    JUVERDERM (VOLUME/CONCENTRATION UNKNOWN)

    MDR report key: 4833604 · Received June 8, 2015

    Report

    Report Number
    3005113652-2015-00267
    Event Type
    Injury
    Date Received
    June 8, 2015
    Date of Event
    May 1, 2015
    Report Date
    May 11, 2015
    Manufacturer
    ALLERGAN
    Product Code
    LMH
    PMA / PMN Number
    P050047
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    FURTHER INFORMATION FROM THE REPORTER REGARDING EVENT PRODUCT OR PATIENT DETAILS HAS BEEN REQUESTED. NO ADDITIONAL INFORMATION IS AVAILABLE AT THIS TIME. ALLERGAN IS UNABLE TO CONFIRM WITH THE HEALTHCARE PROFESSIONAL, THEREFORE ADDITIONAL EVENT, PRODUCT, OR PATIENT DETAILS ARE NOT ATTAINABLE. THE EVENTS OF "BLACK AND BLUE, FACE BLEW UP AND BECAME VERY SWOLLEN," BRUISING, LACK OF CORRECTION AND BUMP ARE PHYSIOLOGICAL COMPLICATIONS AND ANALYSIS OF THE DEVICE GENERALLY DOES NOT ASSIST ALLERGAN IN DETERMINING A PROBABLE CAUSE FOR THESE EVENTS.

    Description of Event or Problem · 1

    PATIENT REPORTED THAT ON THE DAY OF INJECTION "ABOUT 10 DAYS AGO" IN THE "LINES ON THE SIDE OF MOUTH DOWN TO THE CHIN" WITH ONE SYRINGE OF JUVERDERM, THEY EXPERIENCED "A PEA SIZE BLACK AND BLUE MARK" ON THE RIGHT SIDE AT THE INJECTION SITE AND "A TINY BLACK AND BLUE MARK" ON THE LEFT SIDE AT THE INJECTION SITE. PATIENT STATED THAT THE NEXT DAY THE RIGHT SIDE "BLEW UP AND BECAME VERY SWOLLEN, AND THE BLACK AND BLUE AREA GOT BIGGER". PATIENT STATED THAT THE RIGHT SIDE SWELLING EXTENDED TO THE LIP AND THE AREA WAS BRUISED. APPROXIMATELY ONE WEEK LATER, THE BLACK AND BLUE AND BRUISING RESOLVED ON THE RIGHT SIDE BUT THE PATIENT STATED THEY CAN NOW "SEE THE WRINKLE AGAIN" ON THE RIGHT SIDE AND THE CORRECTION IS GONE. RIGHT SIDE SWELLING HAS GONE DOWN QUITE A BIT. PATIENT STATED THAT WHEN THEY SQUEEZE THE RIGHT SIDE INJECTION SITE, THEY CAN FEEL A TINY BUMP, AND IT IS STILL A LITTLE SWOLLEN. SYMPTOMS ON THE LEFT SIDE HAVE RESOLVED. NO TREATMENT HAS BEEN GIVEN TO THE PATIENT, BUT THE PATIENT SELF PRESCRIBED ORAL ARNICA THE DAY AFTER INJECTION. SYMPTOMS ARE ONGOING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    367710 JUVERDERM (VOLUME/CONCENTRATION UNKNOWN) LMH ALLERGAN NA NI

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR Required Intervention "MEDICATIONS"