BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OS-400

    MDR report key: 22145483 · Received June 4, 2025

    Report

    Report Number
    2242863-2025-00001
    Event Type
    Injury
    Date Received
    June 4, 2025
    Date of Event
    May 8, 2025
    Report Date
    June 4, 2025
    Manufacturer
    TOPCON HEALTHCARE, INC.
    Product Code
    HMD
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    501

    Narratives

    Additional Manufacturer Narrative · 0

    THE OS-400 OPERATED AS INTENDED. THE STOOL IS ON WHEELS TO ALLOW FOR EFFECTIVE REPOSITIONING OF THE USER DURING EXAMINATION. EVIDENT BY THE DESCRIPTION OF THE INCIDENT PROVIDED BY THE HEALTH FACILITY, THE PATIENT CAN BE ASSUMED TO HAVE BEEN AWARE THAT THE STOOL HAD WHEELS PRIOR TO THE INCIDENT BECAUSE THE PATIENT WAS UTLIZING THE STOOL FOR THE LENGTH OF THE EXAMINATION PRIOR TO THE INCIDENT. FURTHERMORE, THE PATIENT'S DISTRACTION DUE TO THE USE OF THEIR PHONE CAN BE CONCLUDED TO HAVE CONTRIBUTED GREATLY TO THE CAUSE OF THE INCIDENT SINCE THE PATIENT WAS ABLE TO EFFECTIVELY SIT ON THE STOOL ORIGINALLY WITHOUT INCIDENT.

    Description of Event or Problem · 0

    A PATIENT WENT FOR AN OPHTHALMIC EXAM. DURING THE EXAMINATION, THE PATIENT SAT ON AN OS-400 OPHTHALMIC STOOL. AT THE END OF THE EXAM, THE PATIENT'S PHONE BEGAN RINGING AND THEY STOOD UP FROM THE STOOL. UPON ATTEMPTING TO SIT BACK DOWN WITH THEIR PHONE IN HAND, THE STOOL ROLLED AWAY. CONSEQUENTLY, THE PATIENT FELL TO THE GROUND AND COLLIDED WITH THE STOOL. THE PATIENT WAS TAKEN TO AN EMERGENCY ROOM DUE TO SWELLING IN THE LEFT HAND AND REPORTEDLY HITTING THE BACK OF HER HEAD. THE PATIENT WAS SUBSEQUENTLY DISCHARGED FROM THE EMERGENCY DEPARTMENT THE SAME DAY AFTER AN X-RAY CONFIRMED NO FRACTURE IN THE HAND. NO MALFUNCTION WAS REPORTED WITH THE STOOL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    80200 OS-400 OPHTHALMIC STOOL, MANUAL HMD TOPCON HEALTHCARE, INC. 26014-BL-000 466916

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Female Other