BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DERMALUX FLEX

    MDR report key: 20664292 · Received November 8, 2024

    Report

    Report Number
    MW5162347
    Event Type
    Malfunction
    Date Received
    November 8, 2024
    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 (B)(6) LIGHTS FAILED (B)(6). THE DEVICE WASN'T PHYSICALLY CHECKED BUT DEEMED BEYOND REPAIR FROM A PHOTO. (B)(6) 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 (B)(6) 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: MW5162346.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    975798 DERMALUX FLEX POWERED LASER SURGICAL INSTRUMENT GEX AESTHETIC TECHNOLOGY LTD

    Patients

    Seq Age Sex Outcome Treatment
    1 51 YR Female