BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    JUVEDERM ULTRA PLUS XC TSK US

    MDR report key: 6812229 · Received August 22, 2017

    Report

    Report Number
    3005113652-2017-00886
    Event Type
    Malfunction
    Date Received
    August 22, 2017
    Date of Event
    July 24, 2017
    Report Date
    August 22, 2017
    Manufacturer
    ALLERGAN (PRINGY)
    Product Code
    LMH
    UDI-DI
    30888628000111
    PMA / PMN Number
    P050047
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NV, US
    Reporter Occupation
    PHYSICIAN ASSISTANT

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE ANALYSIS SUMMARY: VISUAL ANALYSIS INDICATES, "THE 3MM LER LOCK IS BROKEN, A SMALL PART OF PLASTIC IS MISSING." FURTHER INFORMATION FROM THE REPORTER REGARDING EVENT HAS BEEN REQUESTED. NO ADDITIONAL INFORMATION IS AVAILABLE AT THIS TIME. A REVIEW OF THE DEVICE HISTORY RECORD HAS BEEN COMPLETED. NO DEVIATIONS OR NON-CONFORMANCES NOTED. DEVICE LABELING: 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 1 SYRINGE OF JUVÉDERM® ULTRA PLUS XC, HAD "BROKEN AT THE TIP OF THE SYRINGE DURING INJECTION AND PRODUCT SPILT ONTO THE PATIENT." PATIENT CONTACT WAS MADE. NO INJURIES OCCURRED. THE PACKAGED NEEDLE WAS USED FOR THE INJECTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    591437 JUVEDERM ULTRA PLUS XC TSK US IMPLANT, DERMAL, FOR AESTHETIC USE LMH ALLERGAN (PRINGY) H30LA70160 30888628000111

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR Other