BEUDAMED
    FDA Adverse Event Injury Summary report: N

    JUVEDERM (VOLUME/CONCENTRTATION UNK)

    MDR report key: 3913236 · Received June 11, 2014

    Report

    Report Number
    3005113652-2014-00245
    Event Type
    Injury
    Date Received
    June 11, 2014
    Date of Event
    May 17, 2014
    Report Date
    May 19, 2014
    Manufacturer
    ALLERGAN
    Product Code
    LMH
    PMA / PMN Number
    P050047
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    ID, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    FURTHER INFO FROM THE REPORTER REGARDING EVENT, PRODUCT, OR PATIENT DETAILS HAS BEEN REQUESTED. NO ADD'L INFO IS AVAILABLE AT THIS TIME. THE EVENT OF "ANGIOEDEMA, SWELLING, COULDN'T BREATHE" 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 THAT IMMEDIATELY AFTER INJECTION WITH JUVEDERM IN THE LIPS, THE PT EXPERIENCED "ANGIOEDEMA, SWELLING" AT THE INJECTION SITE, AS WELL AS "COULDN'T BREATHE." MEDROL DOSEPAK, BENADRYL, AND "STEROID INJECTION" WERE PROVIDED AS TREATMENT BY THE INJECTOR AT THAT TIME. THE PT WAS SUBSEQUENTLY ADMITTED TO THE HOSP THAT SAME DAY AND WAS TREATED WITH PEPCID, BENADRYL, PREDNISONE, AND :PEPCID IV." SYMPTOMS WERE ONGOING TWO DAYS LATER AT THE TIME OF REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    343843 JUVEDERM (VOLUME/CONCENTRTATION UNK) LMH ALLERGAN NA NI

    Patients

    Seq Age Sex Outcome Treatment
    1 40 YR Hospitalization| R ASACOL| "ANTIDEPRESSANT"| CYMBALTA