BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ALIYA BY NEAUVIA

    MDR report key: 24953889 · Received April 22, 2026

    Report

    Report Number
    MW5187147
    Event Type
    Injury
    Date Received
    April 22, 2026
    Date of Event
    February 14, 2026
    Report Date
    April 21, 2026
    Manufacturer
    BERGER & KRAFT
    Product Code
    GEX
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    NC, US
    Reporter Occupation
    PATIENT
    Health Professional
    *

    Narratives

    Description of Event or Problem · 0

    THE REPORTER STATED THAT THE DEVICE WAS INSTALLED ON FEBRUARY 9. SHORTLY AFTER INSTALLATION, THE DEVICE BEGAN LEAKING. AN INDIVIDUAL WHO INITIALLY ASSESSED THE ISSUE SUGGESTED THE DEVICE MAY HAVE BEEN OVERFILLED. ON FEBRUARY 17, A SERVICE REPRESENTATIVE RETURNED TO REPAIR THE DEVICE; HOWEVER, THE DEVICE CONTINUED TO LEAK AND REPORTEDLY ALMOST CAUSED A BURN TO THE REPORTER¿S ARMPIT. A SUBSEQUENT SERVICE VISIT WAS CONDUCTED, AND THE DEVICE WAS REPAIRED A SECOND TIME, BUT THE LEAKING ISSUE RECURRED. THE REPORTER ALSO INDICATED THAT A DEMONSTRATION DEVICE THAT WAS GIVEN TO THEM BY THE COMPANY CAUSED A BURN TO THEIR HAND UPON USE. THE REPORTER STATED THEY FOLLOWED THE INSTRUCTIONS PROVIDED IN THE DEVICE MANUAL, YET STILL SUSTAINED A BURN. NO ADDITIONAL INFORMATION REGARDING MEDICAL TREATMENT OR DEVICE STATUS WAS PROVIDED. PT: 1757. DEVICE: 2404, 1250. REF: MW5187148.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    295044 ALIYA BY NEAUVIA POWERED LASER SURGICAL INSTRUMENT GEX BERGER & KRAFT

    Patients

    Seq Age Sex Outcome Treatment
    1 33 YR Female