BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RAZ-CAT

    MDR report key: 23545334 · Received November 13, 2025

    Report

    Report Number
    3006055387-2025-00002
    Event Type
    Injury
    Date Received
    November 13, 2025
    Date of Event
    October 4, 2025
    Report Date
    November 13, 2025
    Manufacturer
    RAZ DESIGN INC.
    Product Code
    INN
    UDI-DI
    00628758003038
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    BASED ON THE INITIAL INVESTIGATION AFTER PICTURES REVIEW, IT HAS BEEN IDENTIFIED THAT UNAUTHORIZED MODIFICATIONS WERE MADE TO THE SEAT, AND THE REAR BRACKETS WERE NOT PROPERLY ADJUSTED. AFTER DOING TEST, IT HAS BEEN IDENTIFIED THAT IMPROPER ASSEMBLY SIGNIFICANTLY LOWERS STRENGTH (AS LOW AS ~54 LB-F COMPARED TO >150 LB-F UNDER CORRECT ASSEMBLY). AFTER COMPLETING INVESTIGATION, RAZ MANAGEMENT TEAM WILL DECIDE TO IMPLEMENT CORRECTIVE ACTION PLAN IF NEEDED AND REPORT TO REGULATORY AUTHORITIES ACCORDINGLY. AS OF NOW, RAZ IS UNABLE TO FIND CONCLUSIVE CODES ASKED IN SECTION H. SO THIS CAN BE CHANGED IN FINAL OR UPDATED REPORT. IT IS HARD TO FIND THE EXACT DETAILS WITHOUT COMPLETING INVESTIGATION.

    Description of Event or Problem · 0

    ON OCTOBER 16, 2025, THE CANADIAN DISTRIBUTOR REPORTED RAZ THAT ON (B)(6) 2025, A CLIENT AT THE GROUP HOME SUSTAINED A SERIOUS INJURY WITH A CLIENT, (B)(6), 70 YEARS OLD WITH DEVELOPMENT DISABILITIES, INVOLVING A COMMODE WITH FRONT AND REAR SEAT OPENING. 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, SHE IS CURRENTLY HAVING DAILY CARE WITH PACKING CHANGING, SHE HAD A CATHETER WHICH HAS BEEN REMOVED. THERE HAS BEEN MANY LIFESTYLE CHANGES DUE TO THIS INCIDENT, HER CURRENT WHEELCHAIR IS UNUSABLE, NEEDED A NEW SLING. HAS SWITCHED TO BED-BATH.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1984460 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