BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RAZ-SP

    MDR report key: 24408453 · Received February 20, 2026

    Report

    Report Number
    3006055387-2026-00001
    Event Type
    Injury
    Date Received
    February 20, 2026
    Date of Event
    January 1, 2026
    Report Date
    February 20, 2026
    Manufacturer
    RAZ DESIGN INC.
    Product Code
    INN
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    RAZ DESIGN INC. HAS NOT RECEIVED ANY DETAILED INFORMATION, PHOTOGRAPHS, OR SUPPORTING EVIDENCE REGARDING THE REPORTED INCIDENT. AT THIS TIME, RAZ IS AWAITING ADDITIONAL INFORMATION IN ORDER TO INITIATE A FULL AND PROPER INVESTIGATION. SECTION H6 HAS BEEN COMPLETED BASED ON PRELIMINARY ASSUMPTIONS. THE SELECTED CODES ARE THEREFORE PROVISIONAL AND MAY BE INCORRECT. THESE ENTRIES WERE REQUIRED TO PROCEED WITH THE FORM; HOWEVER, THEY WILL BE UPDATED AS NECESSARY ONCE FURTHER DETAILS ARE RECEIVED AND THE INVESTIGATION PROGRESSES.

    Description of Event or Problem · 0

    RAZ HAS BEEN SERVED WITH A LAWSUIT FROM THE MORGAN & MORGAN (LAW FIRM). THERE IS AN ALLEGATION THAT ON (B)(6) 2026, RAZ MOBILE SHOWER COMMODE CHAIR (RAZ-SP) FAILED, BROKE AND IMPALED USER, CAUSING USER TO SUSTAIN SIGNIFICANT AND CATASTROPHIC INJURIES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    177592 RAZ-SP COMMODE, MANUAL INN RAZ DESIGN INC. RAZ-SP

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Female Hospitalization| R