BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DRIVE

    MDR report key: 23140069 · Received September 24, 2025

    Report

    Report Number
    3007309323-2025-00002
    Event Type
    Injury
    Date Received
    September 24, 2025
    Date of Event
    March 23, 2025
    Report Date
    April 9, 2025
    Manufacturer
    ZHENJIANG ASSURE MEDICAL EQUIPMENT CO LTD
    Product Code
    ITJ
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    003

    Narratives

    Description of Event or Problem · 0

    DRIVE DEVILBISS HEALTHCARE WAS NOTIFIED OF AN INCIDENT INVOLVING A ROLLATOR BY THE END USER'S SPOUSE, WHO STATED THAT THE FRONT RIGHT WHEEL FELL OFF DURING USE CAUSING THE END USER TO FALL. SUBSEGUENT X-RAYS REVEALED NO ADDITIONAL INJURIES HOWEVER THE DOCTOR ADVISED THE END USER WIL MOST IKELY NEED PHYSICAL THERAPY AS THE FALL "'EXACERBATED PREVIOUS FRACTURES." AS PART OF ITS COMPLAINTREVIEW AND EVALUATION PROCESS. DRIVE DEVILBISS HEALTHCARE WILL ALSO NOTIFY THE MANUFACTURER OF THE PRODUCT ABOUT THIS COMPLAIN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2384591 DRIVE WALKER, MECHANICAL ITJ ZHENJIANG ASSURE MEDICAL EQUIPMENT CO LTD 102662BL

    Patients

    Seq Age Sex Outcome Treatment
    1 86 YR Female Required Intervention