BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DEFLUX INJECTABLE GEL

    MDR report key: 19726687 · Received July 11, 2024

    Report

    Report Number
    3014909464-2024-00009
    Event Type
    Malfunction
    Date Received
    July 11, 2024
    Date of Event
    July 4, 2024
    Report Date
    July 8, 2024
    Manufacturer
    PALETTE LIFE SCIENCES
    Product Code
    LNM
    UDI-DI
    00850004725009
    PMA / PMN Number
    P000029
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SP
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    QN# (B)(4). COMPLAINT VERIFICATION TESTING COULD NOT BE PERFORMED AS NO SAMPLE WAS RETURNED FOR ANALYSIS. A DEVICE HISTORY RECORD REVIEW WAS PERFORMED, AND NO RELEVANT FINDINGS WERE IDENTIFIED. WITHOUT THE DEVICE TO EVALUATE THE COMPLAINT COULD NOT BE CONFIRMED AND THE PROBABLE CAUSE COULD NOT BE DETERMINED FROM THE AVAILABLE INFORMATION. PALETTE LIFE SCIENCES WILL CONTINUE TO MONITOR AND TREND FOR REPORTS OF THIS NATURE. IN SECTION D PROVIDED THE FULL UDI NUMBER. OTHER REMARKS: N/A; CORRECTED DATA: N/A.

    Additional Manufacturer Narrative · 0

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

    Description of Event or Problem · 0

    ON 08-JUL-2024, PALETTE LIFE SCIENCES RECEIVED NOTIFICATION OF THE FOLLOWING EVENT FROM THE [DISTRIBUTOR], WHO RECEIVED IT FROM A [HOSPITAL] IN SPAIN "DURING THE INJECTION, THE WINGS OF THE SYRINGE HAVE BROKEN." ADDITIONAL INFORMATION WAS RECEIVED ON 08-JUL-2024 FROM THE REPORTER "THE [PHYSICIAN] HURT THE FINGER BUT DIDN'T NEED ANY SURGICAL I NTERVENTION."

    Description of Event or Problem · 0

    ON 08-JUL-2024, PALETTE LIFE SCIENCES RECEIVED NOTIFICATION OF THE FOLLOWING EVENT FROM THE [DISTRIBUTOR], WHO RECEIVED IT FROM A [HOSPITAL] IN SPAIN "DURING THE INJECTION, THE WINGS OF THE SYRINGE HAVE BROKEN." ADDITIONAL INFORMATION WAS RECEIVED ON 08-JUL-2024 FROM THE REPORTER "THE [PHYSICIAN] HURT THE FINGER BUT DIDN'T NEED ANY SURGICAL INTERVENTION."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2385369 DEFLUX INJECTABLE GEL AGENT, BULKING, INJECTABLE F LNM PALETTE LIFE SCIENCES 20377-1 00850004725009

    Patients

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