BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VOLBELLA WITH LIDOCAINE

    MDR report key: 8134853 · Received December 5, 2018

    Report

    Report Number
    3005113652-2018-01616
    Event Type
    Malfunction
    Date Received
    December 5, 2018
    Date of Event
    November 6, 2018
    Report Date
    January 2, 2019
    Manufacturer
    ALLERGAN (PRINGY)
    Product Code
    LMH
    UDI-DI
    10888628032460
    PMA / PMN Number
    P110033
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 0

    CORRECTED INFORMATION:

    Description of Event or Problem · 0

    HEALTHCARE PROFESSIONAL REPORTED THAT ONE SYRINGE OF JUVÉDERM VOLBELLA® XC "LEAKED." THE HEALTHCARE PROFESSIONAL INDICATED THAT IT APPEARS THERE ARE "TINY LITTLE CRACKS" WHERE THE 0.1CC MARKING IS ON THE SYRINGE. PATIENT CONTACT OCCURRED. NO INJURIES WERE REPORTED. THE PACKAGED NEEDLE WAS USED.

    Additional Manufacturer Narrative · 1

    FURTHER INFORMATION REGARDING EVENT, PRODUCT, OR PATIENT DETAILS HAS BEEN REQUESTED. NO ADDITIONAL INFORMATION IS AVAILABLE AT THIS TIME. DEVICE ANALYSIS: VISUAL ANALYSIS OF THE DEVICE INDICATES EMPTY SYRINGE OF 1.0 ML RECEIVED WITH A NEEDLE NOT BELONGING TO ALLERGAN STILL ATTACHED TO SYRINGE, IN AN OPENED "TRY" & PACK. CRACKS OBSERVED AT THE 3 MM LUER LOCK LEVEL. A REVIEW OF THE DEVICE HISTORY RECORD HAS BEEN INITIATED. IF ANY NEW, CHANGED OR CORRECTED INFORMATION IS NOTED, A SUPPLEMENTAL MEDWATCH WILL BE SUBMITTED. 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 ONE SYRINGE OF JUVÉDERM VOLBELLA® XC "LEAKED." THE HEALTHCARE PROFESSIONAL INDICATED THAT IT APPEARS THERE ARE "TINY LITTLE CRACKS" WHERE THE 0.1CC MARKING IS ON THE SYRINGE. PATIENT CONTACT OCCURRED. NO INJURIES WERE REPORTED. THE PACKAGED NEEDLE WAS USED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    975707 VOLBELLA WITH LIDOCAINE IMPLANT, DERMAL, FOR AESTHETIC USE LMH ALLERGAN (PRINGY) V15LA70730 10888628032460

    Patients

    Seq Age Sex Outcome Treatment
    1 44 YR Other