BEUDAMED
    FDA Adverse Event Injury Summary report: N

    JUVEDERM (VOLUME/CONCENTRATION UNKNOWN)

    MDR report key: 2822459 · Received November 2, 2012

    Report

    Report Number
    3005113652-2012-00108
    Event Type
    Injury
    Date Received
    November 2, 2012
    Date of Event
    November 17, 2011
    Report Date
    October 5, 2012
    Manufacturer
    ALLERGAN
    Product Code
    LMH
    PMA / PMN Number
    P050047
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    NO INFORMATION

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    PATIENT REPORTED THAT APPROXIMATELY ONE MONTH AFTER HAVING BOTOX INJECTED INTO THE EYEBROWS AND AROUND THE EYES, AND APPROXIMATELY THIRTEEN DAYS AFTER AN INJECTION OF JUVEDERM IN THE LIPS, THE PATIENT TRAVELED OUTSIDE THE COUNTRY AND EXPERIENCED "EXTREME FATIGUE", "COULD NOT SWALLOW", AND WAS "...WAS SO WEAK". THREE DAYS LATER BACK IN THE U.S., THE PATIENT WAS "BARELY ABLE TO SPEAK OR WALK" AND IT WAS "AS IF [THE PATIENT] SUFFERED A STROKE". THE FOLLOWING DAY, THE PATIENT WENT TO AN EMERGENCY ROOM AND WAS ADMITTED TO THE HOSPITAL THERE FOR APPROXIMATELY A MONTH. PATIENT WAS TREATED WITH "MANY TESTS PERFORMED WITH NO DEFINITE DIAGNOSIS, BUT [THE EVALUATION WAS] LEANING TOWARD MYASTHENIA GRAVIS. [THE PATIENT] "WAS TREATED FOR THIS, BUT DID NOT RESPOND TO THE TREATMENT". PATIENT TRANSFER TO A DIFFERENT FACILITY AND WAS SEEN BY MULTIPLE DOCTORS, HAD A FEEDING TUBE PLACED IN ABDOMEN (REMOVED APPROXIMATELY TWO MONTHS LATER) AND UNDERWENT "MANY TESTS" INCLUDING "TREATMENT OF LAMBERT EATON" ("FOR 1 MONTH WITH NO MARKED IMPROVEMENT"), WITH "THE POSSIBILITY OF LUNG CANCER" (RULED OUT). PER THE PATIENT, LAMBERT EATON WAS NOT CONFIRMED, AND THE PATIENT THEN CONTINUED TO "IMPROVE SLOWLY [ON OWN] WITH NO MEDICATIONS". ADDITIONAL DESCRIPTIONS OF SYMPTOMS REPORTED AS EXPERIENCED OVER THE COURSE OF THE EVENT: "LOSS OF STRENGTH AND MUSCLE WEAKNESS ALL OVER BODY", UNABLE TO LIFT LEFT ARM WITHOUT HELP, LEFT EYELID WAS DROPPING SLIGHTLY", AND "COULD NOT TURN MYSELF WITHOUT USING THE RAILS, [AS] IT WAS EXTREMELY DIFFICULT". [THE PATIENT] REPORTED NOT BEING ABLE TO "TAKE ANYTHING BY MOUTH DUE TO THE INABILITY TO SWALLOW" (FOR APPROXIMATELY 2 MONTHS) AND RECEIVING "SWALLOW PHYSICAL THERAPY" FOR THIS. PATIENT "SLOWLY REGAINED STRENGTH" AND STATED THAT IT WAS RECOMMENDED BY [THE PATIENT'S] HEALTH PROFESSIONALS THAT [THE PATIENT] NOT USE BOTOX OR JUVEDERM IN THE FUTURE. SUPPLEMENTAL INFORMATION OBTAINED FROM THE PATIENT: PATIENT HAS A HISTORY OF PRIOR USE OF BOTOX AND JUVEDERM WITHOUT COMPLAINT. PATIENT'S DOCTORS CANNOT DECISIVELY DETERMINE THE ROOT CAUSE, HOWEVER, HER BOTOX INJECTING OFFICE IS LEANING TOWARD BOTOX. PATIENT CONFIRMED THAT STROKE, MYASTHENIA GRAVIS, LAMBERT EATON AND LUNG CANCER HAVE ALL BEEN RULED OUT. NOTHING RELATED TO OUR OF COUNTRY TRAVEL HAD BEEN PRESENTED TO HER AS A POSSIBLE CAUSE. PATIENT STATED THAT BLOOD WORK WAS SENT TO MAYO CLINIC AND WAS CONSIDERED "INCONCLUSIVE". PATIENT STATED THAT WHILE FOLLOW UP EVALUATION IS SCHEDULED, THE PATIENT CONSIDERS THE SYMPTOMS RESOLVED AT THIS TIME. TO DATE ALLERGAN HAS NOT BEEN ABLE TO CONFIRM THE PATIENT'S REPORTED EVENTS ALTHOUGH FOLLOW UP IS IN PROGRESS.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 NI Hospitalization| R