BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PSORIA LIGHT

    MDR report key: 9271732 · Received November 1, 2019

    Report

    Report Number
    MW5090847
    Event Type
    Malfunction
    Date Received
    November 1, 2019
    Report Date
    October 30, 2019
    Manufacturer
    PSORIA SHIELD, INC.
    Product Code
    FTC
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    THIS MEDICAL DEVICE DOES NOT WORK AS ADVERTISED AND CLAIMED TO THE FDA. WE HAVE MADE MULTIPLE COMPLAINTS TO THE PSORIA-SHIELD AND WELLNESS CENTER USA, INC. (HOLDING COMPANY FOR PSORIA-SHIELD) ABOUT THE PRODUCT FAILURE FOR CLOSE TO 2 YEARS. THEY HAVE IGNORED VIRTUALLY ALL OF OUR COMPLAINTS AND REQUESTS FOR REPAIRS, REPLACEMENTS, AND REFUND. THEY FINALLY TRIED TO REPAIR THE DEVICE EARLIER THIS YEAR AND WERE UNABLE TO. THEY REPLACED OUR NEW UNIT A USED AND DEFECTIVE UNIT. IT SEEMS THEIR UNITS ARE DEFECTIVE OR THEY ARE SPECIFICALLY SENDING US DEFECTIVE UNITS. WE PAID (B)(6) FOR THIS PRODUCT AND HAVE FACED NOTHING BUT FALSE CLAIMS AND PROMISES. AS A RESULT OF THIS COMPANIES DERELICTION OF DUTY, OUR PT HAS NOW LOST ALMOST ALL OF HER HAIR DUE TO ALOPECIA. THIS IS DEVASTATING TO THIS YOUNG GIRL. FDA SAFETY REPORT ID# (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1064076 PSORIA LIGHT LIGHT ULTRAVIOLET, DERMATOLOGICAL FTC PSORIA SHIELD, INC. PL 1000

    Patients

    Seq Age Sex Outcome Treatment
    1