BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DRIVE DEVILBISS HEALTHCARE

    MDR report key: 20301609 · Received September 25, 2024

    Report

    Report Number
    2438477-2024-00050
    Event Type
    Injury
    Date Received
    September 25, 2024
    Date of Event
    June 12, 2024
    Report Date
    September 25, 2024
    Manufacturer
    COM-DA HEALTHCARE CO.,LTD
    Product Code
    IPS
    UDI-DI
    00612479222694
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Distributor report
    Reporter Location
    SC, US
    Reporter Occupation
    003

    Narratives

    Description of Event or Problem · 0

    DRIVE DEVILBISS HEALTHCARE WAS NOTIFIED OF AN INCIDENT INVOLVING A CANE BY THE END USER WHO STATED THE CANE COLLAPSED WHILE IN USE CAUSING THE END USER TO FALL. THE END USER REPORTED SUSTAINING MULTIPLE INJURIES, INCLUDING VERTIGO AND "BLACKING OUT," UNSPECIFIED INJURY TO HIS RIGHT KNEE, AND CUTS AND BRUISES TO HIS EYE AND ARM, RESULTING IN A THREE-DAY HOSPITALIZATION AND SUBSEQUENT FALLS CAUSING FURTHER INJURY TO HIS RIBS AND SPINE. 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
    2199178 DRIVE DEVILBISS HEALTHCARE CANE IPS COM-DA HEALTHCARE CO.,LTD 146-10301F-4 00612479222694

    Patients

    Seq Age Sex Outcome Treatment
    1 80 YR Male Hospitalization