BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DRIVE DEVILBISS HEALTHCARE

    MDR report key: 20091573 · Received August 28, 2024

    Report

    Report Number
    2438477-2024-00045
    Event Type
    Injury
    Date Received
    August 28, 2024
    Date of Event
    August 8, 2024
    Report Date
    August 28, 2024
    Manufacturer
    COM-DA HEALTHCARE CO.,LTD
    Product Code
    ITJ
    UDI-DI
    00822383233208
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Distributor report
    Reporter Location
    OH, US
    Reporter Occupation
    003

    Narratives

    Description of Event or Problem · 0

    DRIVE DEVILBISS HEALTHCARE WAS NOTIFIED OF AN INCIDENT INVOLVING A ROLLATOR BY THE PROVIDER WHO STATED THAT THE WALKER BECAME "WOBBLY", THE LEG BROKE AND THE END USER FELL. THE END USER SUSTAINED LOOSE TEETH AND A LACERATION TO THE LIP. ATTEMPTS TO GATHER ADDITIONAL INFORMATION HAVE BEEN UNSUCCESSFUL. 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
    127827 DRIVE DEVILBISS HEALTHCARE WALKER, MECHANICAL ITJ COM-DA HEALTHCARE CO.,LTD R726BL 00822383233208

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Other