BEUDAMED
    FDA Adverse Event Injury Summary report: N

    JUVEDERM VOLUMA XC 27G 2 X 1ML

    MDR report key: 4092038 · Received August 21, 2014

    Report

    Report Number
    3005113652-2014-00421
    Event Type
    Injury
    Date Received
    August 21, 2014
    Date of Event
    July 12, 2014
    Report Date
    July 28, 2014
    Manufacturer
    ALLERGAN
    Product Code
    LMH
    PMA / PMN Number
    P110033
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE EVENT OF BRUISING, RASH, TIGHTNESS OF THE THROAT, AND REDNESS 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

    HEALTHCARE PROFESSIONAL REPORTED ONE DAY AFTER INJECTION WITH 2 SYRINGES OF JUVEDERM VOLUMA XC IN THE CHEEKS, THE PT CONTACTED THE HEALTHCARE PROFESSIONAL REPORTING BRUISING AT THE INJECTION SITE, A RASH ON THEIR CHEST, TIGHTNESS OF THE THROAT, AND REDNESS ON THE FOREHEAD. THE HEALTHCARE PROFESSIONAL NOTED THAT AT THE TIME OF INJECTION THEY HAD ADVISED THE PATIENT TO APPLY WARM COMPRESSES TO THE INJECTED AREAS IF ANY SWELLING OR BRUISING OCCURRED. IN ADDITIONAL TO CONTACTING THE INJECTING HEALTHCARE PROFESSIONAL, THE PT WENT TO THE EMERGENCY ROOM AND WAS PRESCRIBED ORAL BENADRYL, AN EPIPEN TO TAKE HOME, AND A "SOLU-MEDROL DOSE PACK". ALL OF THE SYMPTOMS RESOLVED 10 DAYS AFTER ONSET. THE HEALTHCARE PROFESSIONAL INDICATED THEY BELIEVED THE SYMPTOMS WERE "PROBABLY NOT" RELATED TO THE JUVEDERM VOLUMA XC AND NOTED THAT THE PT HAD "ALSO EATEN SHELLFISH" AROUND THE TIME OF SYMPTOM ONSET. HOWEVER, THE CAUSE OF THE REACTION HAS NOT BEEN DETERMINED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    504656 JUVEDERM VOLUMA XC 27G 2 X 1ML LMH ALLERGAN NA VB20A40107

    Patients

    Seq Age Sex Outcome Treatment
    1 76 YR Required Intervention