BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SONESTA

    MDR report key: 24018512 · Received January 9, 2026

    Report

    Report Number
    3010496070-2026-00001
    Event Type
    Injury
    Date Received
    January 9, 2026
    Date of Event
    October 6, 2025
    Report Date
    January 9, 2026
    Manufacturer
    SONESTA MEDICAL AB
    Product Code
    IXR
    UDI-DI
    07350006950018
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SW
    Reporter Occupation
    501

    Narratives

    Additional Manufacturer Narrative · 0

    THE MODEL 6210 INCLUDES DETACHABLE ARM RESTS INTENDED FOR PATIENT COMFORT AND ARM POSITIONING DURING CLINICAL PROCEDURES. THE ARM RESTS ARE NOT STRUCTURAL COMPONENTS AND ARE NOT DESIGNED TO SUPPORT PATIENT BODY WEIGHT OR FUNCTION AS SAFETY RAILS. THE REPORTED EVENT OCCURRED DURING POST-PROCEDURE PATIENT HANDLING WHEN THE PATIENT WAS LEANED AGAINST A DETACHABLE ARM REST. THE MANUFACTURER DETERMINED THAT THE EVENT WAS RELATED TO USE OF THE ARM REST OUTSIDE ITS INTENDED PURPOSE AND THAT CURRENT INSTRUCTIONS FOR USE DO NOT SUFFICIENTLY DESCRIBE ARM REST LIMITATIONS. CORRECTIVE ACTIONS ARE BEING IMPLEMENTED TO UPDATE RISK MANAGEMENT DOCUMENTATION AND CLARIFY ARM REST USE AND LIMITATIONS IN THE IFU.

    Description of Event or Problem · 0

    DURING POST-PROCEDURE PATIENT CARE, A PARAPLEGIC PATIENT WAS REPOSITIONED WHILE SEATED ON A MODEL 6210 PROCEDURE CHAIR. DURING DRESSING, THE PATIENT WAS LEANED AGAINST A DETACHABLE ARM REST. THE ARM REST IS INTENDED FOR PATIENT COMFORT AND ARM POSITIONING AND IS NOT DESIGNED TO SUPPORT PATIENT BODY WEIGHT. DURING THIS MANEUVER, THE ARM REST ATTACHMENT CAME LOOSE, AND THE PATIENT FELL FROM THE CHAIR TO THE FLOOR. TWO HEALTHCARE STAFF MEMBERS SUSTAINED BACK INJURIES WHILE ATTEMPTING TO PREVENT THE FALL. ONE STAFF INJURY REQUIRED MEDICAL CARE AND RESULTED IN WORK RESTRICTIONS. THE PATIENT WAS EVALUATED FOLLOWING THE FALL AND NO ACUTE INJURY WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    78776 SONESTA SONESTA 6210 IXR SONESTA MEDICAL AB 0120-LA120-03 07350006950018

    Patients

    Seq Age Sex Outcome Treatment
    1 45 YR Unknown Required Intervention