BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DERMALUX FLEX

    MDR report key: 20664273 · Received November 8, 2024

    Report

    Report Number
    MW5162346
    Event Type
    Malfunction
    Date Received
    November 8, 2024
    Date of Event
    January 8, 2022
    Report Date
    November 6, 2024
    Manufacturer
    AESTHETIC TECHNOLOGY LTD.
    Product Code
    GEX
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    UK
    Reporter Occupation
    UNKNOWN
    Health Professional
    *

    Narratives

    Description of Event or Problem · 0

    PURCHASED A DERMALUX FLEX LED DEVICE MAR 22 LIGHTS FAILED AUG 22. THE DEVICE WASN'T PHYSICALLY CHECKED BUT DEEMED BEYOND REPAIR FROM A PHOTO. DEC 23 CABLE WIRES EXPOSED, POPPED LOUD AND SPARKED WHEN PLUGGING IN ( FELT SHOCKED AND SCARED IT COULD OF IGNITED) THE COMPANY JUST REQUIRED A PHOTO TO DIAGNOSE FAULTY NEW CABLE RECEIVED JAN 24 AUGUST 24 LIGHTS FAILED ON 2ND DEVICE AND CABLE ONCE AGAIN EXPOSED THE ACTUAL WIRES. THIS SUPPOSED TO BE MEDICAL APPROVED AND FDA. THE DEVICE IS FLIMSY AND DANGEROUS. ALSO YOUR SUPPOSED TO BE ABLE TO USE IT ON THE BODY YET IT LEAVES MARKS WHERE'S THE BULBS ARE. OTHER ARE EXPERIENCING ISSUES (THIS CAN BE BACKED UP). REF REPORT: MW5162347.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1205255 DERMALUX FLEX POWERED LASER SURGICAL INSTRUMENT GEX AESTHETIC TECHNOLOGY LTD.

    Patients

    Seq Age Sex Outcome Treatment
    1 51 YR Female