BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RAZ-CAT

    MDR report key: 23796837 · Received December 12, 2025

    Report

    Report Number
    3006055387-2025-00003
    Event Type
    Injury
    Date Received
    December 12, 2025
    Date of Event
    October 4, 2025
    Report Date
    December 12, 2025
    Manufacturer
    RAZ DESIGN INC.
    Product Code
    INN
    UDI-DI
    00628758003038
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    TEST CONCLUSION SUGGESTS THAT THERE IS NO RISK OF FRONT SEAT BRACKETS BREAKING UNDER INTENDED USE AS PER INSTRUCTIONS PROVIDED. HOWEVER, TO ENHANCE CUSTOMER SAFETY, FRAME SAVERS WILL BE ADDED TO ALL NEW FAR SEATS AND RETROFIT KITS WILL BE PROVIDED TO EXISTING CUSTOMERS.

    Description of Event or Problem · 0

    ON (B)(6) 2025, THE RAZ CANADIAN DISTRIBUTOR REPORTED RAZ THAT ON (B)(6) 2025, A CLIENT AT THE GROUP HOME SUSTAINED A SERIOUS INJURY INVOLVING A COMMODE. AFTER ASSISTING THE CLIENT WITH A SHOWER AND RETURNING HER TO THE BEDROOM, STAFF NOTICED SHE HAD PARTIALLY FALLEN INTO THE COMMODE OPENING. AS STAFF PREPARED TO REPOSITION HER, THE COMMODE SEAT SNAPPED, CAUSING THE CLIENT TO FALL THROUGH AND SUFFER A RECTAL IMPALEMENT INJURY. STAFF PLACED THE CLIENT ON HER SIDE AND HELD HER IN POSITION UNTIL EMERGENCY HEALTH SERVICES (EHS) ARRIVED. EHS HAD TO CUT THE COMMODE TO FACILITATE SAFE TRANSPORT TO THE HOSPITAL. BECAUSE OF THE COMMODE SEAT SNAPPED, CLIENT FELL THROUGH AND SUFFER A RECTAL IMPALEMENT INJURY. GROUP HOME STAFF PLACED THE CLIENT ON HER SIDE AND HELD HER IN POSITION UNTIL EMERGENCY HEALTH SERVICES (EHS) ARRIVED. EHS HAD TO CUT THE COMMODE TO FACILITATE SAFE TRANSPORT TO THE HOSPITAL. (B)(6) WAS IN THE HOSPITAL FOR 3 WEEKS,

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2762186 RAZ-CAT COMMODE MANUAL (RAZ-CAT) INN RAZ DESIGN INC. RAZ-CAT 00628758003038

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR Female Required Intervention| H