BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ZERIGO HEALTH UVB SMART LIGHT THERAPY DEVICE AND MOBILE

    MDR report key: 23960734 · Received January 5, 2026

    Report

    Report Number
    MW5181737
    Event Type
    Injury
    Date Received
    January 5, 2026
    Date of Event
    August 22, 2025
    Report Date
    December 26, 2025
    Manufacturer
    ZERIGO HEALTH, INC.
    Product Code
    FTC
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    ND, US
    Reporter Occupation
    PATIENT
    Health Professional
    *

    Narratives

    Description of Event or Problem · 0

    I AM SUBMITTING THIS COMPLAINT TO REPORT A SERIOUS ADVERSE EVENT RESULTING FROM MY USE OF THE FDA CLEARED ZERIGO HEALTH UVB SMART LIGHT THERAPY DEVICE, WHICH I USED EARLIER THIS YEAR TO TREAT FACIAL SEBORRHEIC ECZEMA. THE DEVICE WAS PROVIDED TO ME DIRECTLY BY ZERIGO HEALTH FOLLOWING A VIRTUAL CONSULTATION WITH ONE OF THEIR PHYSICIANS. DURING THIS CONSULTATION, THE PHYSICIAN PRESCRIBED THE DEVICE AND SET THE UVB INTENSITY PARAMETERS. THE DEVICE IS INTENDED FOR AT HOME, SELF-ADMINISTERED USE AND IS OPERATED IN CONJUNCTION WITH A MOBILE APPLICATION DEVELOPED BY ZERIGO HEALTH. ON (B)(6) 2025, I PERFORMED MY FIRST TREATMENT USING THE DEVICE. PRIOR TO THIS, I COMPLETED A GUIDED SETUP SESSION WITH A ZERIGO HEALTH REPRESENTATIVE. I FOLLOWED ALL INSTRUCTIONS PROVIDED WITHIN THE ZERIGO HEALTH MOBILE APPLICATION AND USED THE DEVICE TO TREAT THE AFFECTED AREA ON MY CHIN. WITHIN 24 HOURS, I DEVELOPED A SEVERE BURN AT THE TREATMENT SITE. THE SKIN BECAME SIGNIFICANTLY DAMAGED, AND BY THE NEXT DAY, YELLOW FLUID WAS OOZING FROM THE BURN, INDICATING A SERIOUS INJURY. CONCERNED ABOUT THE SEVERITY AND POTENTIAL LONG-TERM EFFECTS, I CONTACTED ZERIGO HEALTH SEVERAL DAYS LATER. ZERIGO HEALTH INFORMED ME THAT THE MOBILE APPLICATION HAD DIRECTED ME TO PERFORM 10 TREATMENTS SQUARES ON THE SAME AREA, RESULTING IN AN EXCESSIVELY HIGH CUMULATIVE UVB DOSE. THIS OVEREXPOSURE DIRECTLY CAUSED THE BURN. I ALSO SOUGHT EVALUATION FROM MY LOCAL DERMATOLOGIST DUE TO THE EXTENT OF THE INJURY. THE WOUND REQUIRED SEVERAL WEEKS OF CARE, DURING WHICH I EXPERIENCED PERSISTENT OOZING, SCABBING, AND SIGNIFICANT DISCOMFORT. BASED ON MY EXPERIENCE, IT IS MY POSITION THAT THE ZERIGO HEALTH UVB SMART LIGHT THERAPY DEVICE SHOULD NOT BE SELF-ADMINISTERED WITHOUT PROFESSIONAL SUPERVISION. THE DEVICE AND ITS ACCOMPANYING MOBILE APPLICATION EXHIBIT SERIOUS DESIGN AND SAFETY FLAWS, INCLUDING DOSING GUIDANCE THAT CAN LEAD TO DANGEROUS OVEREXPOSURE. THESE FLAWS DIRECTLY CONTRIBUTED TO MY INJURY. ZERIGO HEALTH HAS A LEGAL AND ETHICAL OBLIGATION TO ENSURE THAT SELF-ADMINISTERED MEDICAL DEVICES DO NOT POSE FORESEEABLE RISKS TO CONSUMERS. IN THIS CASE, A CLEAR DUTY OF CARE EXISTED, AND ZERIGO HEALTH BREACHED THAT DUTY, RESULTING IN HARM TO ME. I CONTACTED ZERIGO HEALTH TO REPORT THE INJURY AND REQUEST COMPENSATION. MY CONCERNS WERE DISMISSED, AND I WAS INCORRECTLY BLAMED FOR IMPROPER USE, DESPITE THE FACT THAT I FOLLOWED THE INSTRUCTIONS EXACTLY AS PROVIDED IN THEIR MOBILE APPLICATION. AS OF (B)(6) 2025, MY CHIN REMAINS VISIBLY DAMAGED, WITH PERSISTENT REDNESS AND SIGNS OF LONG-TERM INJURY. I AM SUBMITTING THIS REPORT, SO THE FDA IS AWARE OF THE RISKS ASSOCIATED WITH THIS DEVICE AND ITS SOFTWARE GUIDED DOSING INSTRUCTIONS, WHICH IN MY CASE CAUSED A PREVENTABLE AND SIGNIFICANT INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    32162 ZERIGO HEALTH UVB SMART LIGHT THERAPY DEVICE AND MOBILE LIGHT, ULTRAVIOLET, DERMATOLOGICAL FTC ZERIGO HEALTH, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 44 YR Male Required Intervention| O