BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ART THERAPY

    MDR report key: 23618083 · Received November 21, 2025

    Report

    Report Number
    MW5179234
    Event Type
    Injury
    Date Received
    November 21, 2025
    Report Date
    November 19, 2025
    Manufacturer
    UNKNOWN
    Product Code
    PWE
    Adverse Event
    Yes
    Report Source
    Voluntary report
    Reporter Occupation
    OTHER
    Health Professional
    *

    Narratives

    Description of Event or Problem · 0

    THE FOLLOWING AES (ALANINE AMINOTRANSFERASE INCREASED, HYPONATREMIA) WERE REPORTED FOR PATIENT (B)(6). BOTH AES WERE REPORTED AS ¿POSSIBLY RELATED¿ TO ART THERAPY. IF YOU HAVE ANY QUESTIONS REGARDING THIS LETTER FOR MANUFACTURER NOTIFICATION, PLEASE DO NOT HESITATE TO CONTACT US. "THIS REPORT REFLECTS INFORMATION RECEIVED BY FDA IN THE FORM OF A NOTIFICATION PER 803.22 (B)(2)".

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2490706 ART THERAPY COMPUTERIZED BEHAVIORAL THERAPY DEVICE FOR SUBSTANCE USE DISORDERS PWE UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown