BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DRIVE DEVILBISS HEALTHCARE

    MDR report key: 20044029 · Received August 22, 2024

    Report

    Report Number
    2438477-2024-00043
    Event Type
    Injury
    Date Received
    August 22, 2024
    Date of Event
    August 5, 2024
    Report Date
    August 22, 2024
    Manufacturer
    COM-DA HEALTHCARE CO.,LTD
    Product Code
    ILS
    UDI-DI
    00754021210336
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Distributor report
    Reporter Location
    CA
    Reporter Occupation
    003

    Narratives

    Description of Event or Problem · 0

    DRIVE DEVILBISS HEALTHCARE WAS NOTIFIED OF AN INCIDENT INVOLVING A BATH SEAT BY THE END USER'S SON WHO STATED THE DEVICE'S SEAT BROKE CAUSING THE END USER TO FALL. THE END USER LEGS ARE WEAK AND PAINFUL. THE END USER IS HAVING DIFFICULTY WALKING. AS PART OF ITS COMPLAINT REVIEW AND EVALUATION PROCESS, DRIVE DEVILBISS HEALTHCARE WILL ALSO NOTIFY THE MANUFACTURER OF THE PRODUCT ABOUT THIS COMPLAINT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1742831 DRIVE DEVILBISS HEALTHCARE ADAPTOR, HYGIENE ILS COM-DA HEALTHCARE CO.,LTD 770-525 00754021210336

    Patients

    Seq Age Sex Outcome Treatment
    1 76 YR Female Other