BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    JUVEDERM ULTRA PLUS XC TSK US

    MDR report key: 6877766 · Received September 19, 2017

    Report

    Report Number
    3005113652-2017-01078
    Event Type
    Malfunction
    Date Received
    September 19, 2017
    Report Date
    September 19, 2017
    Manufacturer
    ALLERGAN (PRINGY)
    Product Code
    LMH
    UDI-DI
    30888628000111
    PMA / PMN Number
    P050047
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    FURTHER INFORMATION FROM THE REPORTER REGARDING EVENT, PRODUCT, OR PATIENT DETAILS HAS BEEN REQUESTED. NO ADDITIONAL INFORMATION IS AVAILABLE AT THIS TIME. DEVICE LABELING ADDRESSES THE REPORTED EVENT(S) AS FOLLOWS: "PRECAUTIONS ¿ FAILURE TO COMPLY WITH THE NEEDLE ATTACHMENT INSTRUCTIONS COULD RESULT IN NEEDLE DISENGAGEMENT AND/OR PRODUCT LEAKAGE AT THE LUER-LOK® AND NEEDLE HUB CONNECTION."

    Description of Event or Problem · 1

    HEALTHCARE PROFESSIONAL REPORTED THAT ONE SYRINGE OF JUVÉDERM® ULTRA PLUS XC HAD "NEEDLES COMING APART FROM THE SYRINGE." PATIENT CONTACT WAS MADE, BUT NO INJURY WAS REPORTED. THE PACKAGED NEEDLE WAS USED FOR THE INJECTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    655568 JUVEDERM ULTRA PLUS XC TSK US IMPLANT, DERMAL, FOR AESTHETIC USE LMH ALLERGAN (PRINGY) H30LA60478 30888628000111

    Patients

    Seq Age Sex Outcome Treatment
    1 Other