BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DEFLUX INJECTABLE GEL

    MDR report key: 19983600 · Received August 14, 2024

    Report

    Report Number
    3014909464-2024-00013
    Event Type
    Malfunction
    Date Received
    August 14, 2024
    Date of Event
    August 5, 2024
    Report Date
    August 6, 2024
    Manufacturer
    PALETTE LIFE SCIENCES
    Product Code
    LNM
    UDI-DI
    00850004725009
    PMA / PMN Number
    P000029
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SP
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). COMPLAINT EVALUATION TESTING WAS PERFORMED FROM THE SAMPLE RETURNED. ONE SYRINGE WAS RETURNED, AND THE LOT NUMBER IS IN ACCORDANCE WITH THE REPORT. IT WAS OBSERVED THE SYRINGE HAD BEEN USED AND THE FLANGE WAS BROKEN. THERE ARE NO DEVIATIONS OR REMARKS IDENTIFIED IN THE REVIEW OF BATCH RECORDS ON THE REPORTED LOT THAT CAN EXPLAIN THE COMPLAINT. NO QUALITY ISSUES WERE FOUND CONNECTED TO THE RAW MATERIAL (GLASS SYRINGE) WHICH CAN EXPLAIN THE COMPLAINT. THE MOST PROBABLE ROOT CAUSE COULD NOT BE DETERMINED. THE NUMBER OF COMPLAINTS ON THIS BATCH IS LOW. NO FURTHER ACTIONS WILL BE TAKEN REGARDING THIS COMPLAINT. PALETTE LIFE SCIENCES WILL CONTINUE TO MONITOR AND TREND FOR REPORTS OF THIS NATURE.

    Additional Manufacturer Narrative · 0

    (B)(4). N/A. OTHER REMARKS: N/A. CORRECTED DATA: N/A.

    Description of Event or Problem · 0

    ON 06-AUG-2024, PALETTE LIFE SCIENCES RECEIVED A NOTIFICATION OF THE FOLLOWING EVENT FROM THE [DISTRIBUTOR], WHO RECEIVED IT FROM A [ HOSPITAL] IN SPAIN "DURING INJECTION, THE WINGS OF THE SYRINGE BROKEN."

    Description of Event or Problem · 0

    ON 06-AUG-2024 PALETTE LIFE SCIENCES RECEIVED A NOTIFICATION OF THE FOLLOWING EVENT FROM THE [DISTRIBUTOR], WHO RECEIVED IT FROM A [ HOSPITAL] IN SPAIN "DURING INJECTION, THE WINGS OF THE SYRINGE BROKEN."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    552772 DEFLUX INJECTABLE GEL AGENT, BULKING, INJECTABLE F LNM PALETTE LIFE SCIENCES 20852-1 00850004725009

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown NONE REPORTED.| NONE REPORTED.