BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    XTRALLUX

    MDR report key: 23492515 · Received November 6, 2025

    Report

    Report Number
    3025432379-2025-00006
    Event Type
    Malfunction
    Date Received
    November 6, 2025
    Date of Event
    October 3, 2025
    Report Date
    November 6, 2025
    Manufacturer
    XTRALLUX, LLC
    Product Code
    OAP
    PMA / PMN Number
    K222364
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    THE DEVICE WAS NOT RETURNED FOR INVESTIGATION, AND THUS, A ROOT CAUSE WAS UNABLE TO BE DETERMINED. HOWEVER, IMAGES SHARED BY THE REPORTER SHOW EVIDENCE OF HEAT DAMAGE. THE PATIENT DID NOT REPORT ANY HARM ASSOCIATED WITH THE EVENT. THE DEVICE'S RISK ASSESSMENT CAPTURES THE RELATIVE RISK AND HAS DETERMINED IT TO BE ACCEPTABLE. THE DEVICE DHR WAS REVIEWED AND THERE WERE NO NONCONFORMITIES. THE INSTRUCTIONS FOR USE (IFU), WHICH WERE REVIEWED THROUGH THE 510K SUBMISSION, PROVIDE INFORMATION REGARDING ELECTRICAL SHOCK SUCH AS: "DO NOT OPERATE THE DEVICE WHEN IT OR ANY OF ITS COMPONENTS ARE DAMAGED, OR IF THE POWER PACK OR POWER SUPPLY HAVE BEEN DROPPED OR DAMAGED. TO AVOID THE RISK OF ELECTRIC SHOCK, DO NOT DISASSEMBLE ANY PART OF THE APPLIANCE OR ITS ACCESSORIES. CONTACT XTRALLUX CUSTOMER SERVICE FOR EXAMINATION AND REPAIR," AND "IF THE POWER SUPPLY IS DAMAGED, CONTACT XTRALLUX FOR REPLACEMENT TO AVOID ELECTRICAL HAZARD OR DAMAGE." XTRALLUX ALSO ENCOURAGES PATIENTS TO HANDLE THE DEVICE WITH CARE TO MITIGATE RISKS RELATED TO POWER CORD DAMAGE ADVISING, "CARE SHOULD BE TAKEN TO PROTECT THE INTEGRITY OF THE DEVICE. IT IS RECOMMENDED TO KEEP YOUR XTRALLUX DEVICE IN ITS PROTECTIVE STORAGE CASE BETWEEN USES TO PREVENT ACCIDENTAL DAMAGE AND AVOID EXCESS WEAR AND TEAR. TAKE CARE WHEN REMOVING CABLES FROM POWER SOURCES, GENTLY UNPLUGGING CABLES WITHOUT EXERTING EXCESS TENSION ON DEVICE CABLES."

    Description of Event or Problem · 0

    ON 10/08/2025, XTRALLUX RECEIVED COMMUNICATION FROM A PATIENT CLAIMING THAT THE PLUG ON THE BACK OF THE CAP WAS GETTING "SUPER HOT" AND THE PLASTIC WAS BURNT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    171676 XTRALLUX HAIR REGROWTH CAP - PHOTOBIOMODULATING DEVICE OAP XTRALLUX, LLC XTRALLUX EXTREME RX XERX240400023

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown