BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ZERIGO UV LIGHT THERAPY DEVICE

    MDR report key: 23437032 · Received October 31, 2025

    Report

    Report Number
    MW5178357
    Event Type
    Injury
    Date Received
    October 31, 2025
    Date of Event
    April 29, 2025
    Report Date
    October 27, 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 SUSTAINED FIRST- AND SECOND-DEGREE BURNS ON (B)(6) 2025, AFTER USING THE ZERIGO ULTRAVIOLET (UV) LIGHT PHOTOTHERAPY DEVICE FOR PSORIASIS TREATMENT. I FOLLOWED THE INSTRUCTIONS PROVIDED AND WAS ON A VIDEO CALL WITH ZERIGO'S NURSE, MICHELLE, DURING THE SESSION. WITHIN HOURS, I DEVELOPED BLISTERING AND DRAINAGE. A DOCTOR CONFIRMED SECOND-DEGREE BURNS AND PRESCRIBED ANTIBIOTICS AND TOPICAL TREATMENT. ZERIGO'S NURSE LATER INSTRUCTED ME TO DISPOSE OF THE DEVICE RATHER THAN RETURN IT. SINCE THE INJURY, I HAVE HAD ONGOING PAIN, PERMANENT SKIN DISCOLORATION (POST-INFLAMMATORY HYPERPIGMENTATION), AND SEVERE HEAT INTOLERANCE THAT LIMITS DAILY ACTIVITIES AND EXPOSURE TO SUNLIGHT. "CONSUMER HOME DEVICE ¿ SERIAL NOT AVAILABLE, DISPOSED PER NURSE INSTRUCTION."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1906450 ZERIGO UV LIGHT THERAPY DEVICE LIGHT, ULTRAVIOLET, DERMATOLOGICAL FTC ZERIGO HEALTH, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 Female Required Intervention| O CONSENTYX.| LISINOPRIL.