BEUDAMED
    FDA Adverse Event Injury Summary report: N

    JUVEDERM ULTRA XC TSK US

    MDR report key: 4801011 · Received May 27, 2015

    Report

    Report Number
    3005113652-2015-00246
    Event Type
    Injury
    Date Received
    May 27, 2015
    Date of Event
    April 15, 2015
    Report Date
    April 28, 2015
    Manufacturer
    ALLERGAN
    Product Code
    LMH
    UDI-DI
    30888628000081
    PMA / PMN Number
    P050047
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    MEDWATCH SENT TO FDA ON 07/09/2015. DEVICE HISTORY RECORD SUMMARY: THE DOCUMENTARY RESEARCH IN THE BATCH FILE SHOWS THAT NO ELEMENT COULD EXPLAIN THESE REACTIONS ALL THE MANUFACTURING STEPS AND ALL THE PHYSICOCHEMICAL AND MICROBIOLOGICAL RESULTS (ENDOTOXINS, BIOBURDEN) ARE REGISTERED AS CONFORM TO THE SPECIFICATIONS. NO DEVIATION, ANOMALY, COMPLAINT OR CHANGE IN CONNECTION WITH THIS COMPLAINT WERE RECORDED. THE STERILIZATION CYCLE IS REGISTERED AS CONFORM.

    Additional Manufacturer Narrative · 1

    (B)(4). FURTHER INFO FROM THE REPORTER REGARDING EVENT, PRODUCT, OR PT DETAILS HAS BEEN REQUESTED. NO ADDITIONAL INFO IS AVAILABLE AT THIS TIME. THE EVENTS OF PAIN, SWELLING, AND ALLERGIC REACTION 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

    HEALTHCARE REPORTED AFTER INJECTION WITH 2 SYRINGES OF JUVEDERM ULTRA XC IN THE "CHIN AND MOUTH" THAT THE PT EXPERIENCED "PAIN AND SWELLING" ON THE FACE NOTICED ABOUT 5 DAYS AFTER INJECTION. THE PT WAS TREATED ON THE DAY OF ONSET WITH A "MEDROL DOSE PACK AND KELFLEX" TO "HELP GET OVER THE SYMPTOMS." THE HEALTHCARE PROFESSIONAL BELIEVES THE PT MAY BE HAVING AN ALLERGIC REACTION TO THE PRODUCT. SYMPTOMS ARE ONGOING, BUT THE PT IS "DOING BETTER." PT WAS CONCOMITANTLY INJECTED WITH 2 SYRINGES OF JUVEDERM ULTRA PLUS XC IN THE "NASOLABIAL FOLDS, CORNERS OF THE MOUTH, AND LIP LINES." THIS IS THE SAME EVENT AND THE SAME PT REPORTED UNDER MDR ID # 300513652-2015-00245 (ALLERGAN COMPLAINT # 1190627). THIS MDR IS BEING SUBMITTED FOR THE SECOND SUSPECT PRODUCT, JUVEDERM ULTRA XC, ALSO A DEVICE MANUFACTURED BY ALLERGAN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    341611 JUVEDERM ULTRA XC TSK US LMH ALLERGAN H24LA40408 30888628000081

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR Required Intervention ACETONOL| MELOXICAM| JUVEDERM ULTRA PLUS XC| GABAPENTIN| LEXAPRO