BEUDAMED
    FDA Adverse Event Injury Summary report: N

    JUVEDERM VOLUMA XC 27G 2 X 1ML

    MDR report key: 3954712 · Received July 18, 2014

    Report

    Report Number
    3005113652-2014-00329
    Event Type
    Injury
    Date Received
    July 18, 2014
    Date of Event
    April 11, 2014
    Report Date
    June 23, 2014
    Manufacturer
    ALLERGAN
    Product Code
    LMH
    PMA / PMN Number
    P110033
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    FURTHER INFORMATION FROM THE REPORTER REGARDING EVENT, PRODUCT, OR PATIENT DETAILS HAVE BEEN REQUESTED. NO ADDITIONAL INFORMATION IS AVAILABLE AT THIS TIME. THE EVENT OF "SWOLLEN POCKETS" AND "PUFFINESS" 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 11 DAYS AFTER INJECTION WITH 2 SYRINGE OF JUVEDERM XC IN THE CHEEKS AND CONCOMITANT INJECTION OF JUVEDERM ULTRA PLUS XC IN THE NASOLABIAL FOLDS AND "LOWER FACE" PATIENT PRESENTED TO THE HEALTHCARE PROFESSIONAL WITH "SWOLLEN POCKETS" AND "PUFFINESS" IN THE CHEEK AREA. THE PATIENT COMPLAINED OF "HIVE, BLISTER TYPE THINGS" BUT THE HEALTHCARE PROFESSIONAL DID NOT OBSERVE THESE SYMPTOMS DURING ASSESSMENT. THE PATIENT WAS TREATED WITH HYALURONIDASE ON TWO SEPARATE OCCASIONS TO "RESOLVE THE PUFFINESS." THE HEALTHCARE PROFESSIONAL DOES NOT BELIEVE THE PATIENT'S SYMPTOMS ARE RELATED TO THE JUVEDERM PRODUCT INJECTIONS. THEY SPECULATED THAT SINCE THE PATIENT HAD PREVIOUS "FAT PAD SURGERY", PERHAPS THE FILLER "KIND OF PUSHED THE FAT PADS LAYING UNDERNEATH THE SURFACE FORWARD." HOWEVER, THE PATIENT BELIEVES THE SYMPTOMS ARE RELATED TO JUVEDERM AND THE HEALTHCARE PROFESSIONAL INDICATED THEY COULD NOT, WITH CERTAINTY, CONFIRM THE THAT THE JUVEDERM INJECTIONS ARE NOT RELATED TO THE PATIENT'S SYMPTOMS. THE PATIENT HAS REFUSED ADDITIONAL TREATMENT, SYMPTOMS HAVE NOT YET RESOLVED. THIS IS THE SAME EVENT AND THE SAME PATIENT REPORTED UNDER MDR ID # 3005113652-2014-00320 (ALLERGAN COMPLAINT #(B)(4)). THIS IS THE FIRST MDR SUBMITTED FOR THE FIRST SUSPECT PRODUCT, JUVEDERM VOLUMA XC.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    422546 JUVEDERM VOLUMA XC 27G 2 X 1ML LMH ALLERGAN NA VB20A40006

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR Required Intervention JUVEDERM ULTRA PLUS XC INJECTED IN THE| NASOLABIAL FOLDS AND LOWER FACE