BEUDAMED
    FDA Adverse Event Injury Summary report: N

    JUVEDERM VOLUMA XC 27G 2 X 1ML

    MDR report key: 4112840 · Received September 17, 2014

    Report

    Report Number
    3005113652-2014-00455
    Event Type
    Injury
    Date Received
    September 17, 2014
    Date of Event
    August 21, 2014
    Report Date
    August 21, 2014
    Manufacturer
    ALLERGAN
    Product Code
    LMH
    PMA / PMN Number
    P110033
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE EVENT OF "REDNESS", "SWELLING" AND "INFECTION" IS A PHYSIOLOGICAL COMPLICATION AND ANALYSIS OF THE DEVICE GENERALLY DOES NOT ASSIST ALLERGAN IN DETERMINING A REPORTABLE CAUSE FOR THIS EVENT.

    Description of Event or Problem · 1

    HEALTHCARE PROFESSIONAL REPORTED THAT AFTER INJECTION WITH JUVEDERM VOLUMA XC IN THE CHEEKS, THE PT EXPERIENCED RIGHT CHEEK "REDNESS AND SWELLING" TWENTY DAYS AFTER INJECTION. PT WAS CONCOMITANTLY INJECTED WITH JUVEDERM ULTRA PLUS XC IN "BOTH NASOLABIAL FOLDS" THOUGH THE HEALTHCARE PROFESSIONAL HAS EXONERATED THAT PRODUCT DUE TO THE FACT THAT NO ADVERSE EVENTS WERE REPORTED IN REGARDS TO THE JUVEDERM ULTRA PLUS XC INJECTION SITES. ALL SYMPTOMS WERE PRESENTED ON THE RIGHT INJECTION SITE FOR THE JUVEDERM VOLUMA XC. THE HEALTHCARE PROFESSIONAL LATER ALSO STATED THAT "[THE PATIENT] COULD HAVE HAD A BAD INFECTION". PT WAS TREATED WITH AUGMENTIN AND A MEDROL DOSEPAK. ADDITIONAL FOLLOW-UP NOTED SYMPTOMS RESOLVED "ABOUT A WEEK AFTER TREATMENT."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    576103 JUVEDERM VOLUMA XC 27G 2 X 1ML LMH ALLERGAN NA VB20A30431

    Patients

    Seq Age Sex Outcome Treatment
    1 61 YR Required Intervention JUVEDERM ULTRA PLUS XC| "TOPICAL NUMBING CREAM"