BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DRIVE

    MDR report key: 16699645 · Received April 7, 2023

    Report

    Report Number
    3014644996-2023-00002
    Event Type
    Malfunction
    Date Received
    April 7, 2023
    Report Date
    April 7, 2023
    Manufacturer
    COM-DA HEALTHCARE CO.,LTD
    Product Code
    IPS
    UDI-DI
    00822383224916
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 0

    DRIVE DEVILBISS HEALTHCARE WAS NOTIFIED OF AN INCIDENT INVOLVING A CANE BY AN END USER, WHO STATED THAT "WHILE WALKING WITH THE CANE IT GOT WET AND HE SLIPPED AND FELL." THE END USER HIT HIS HEAD BUT DID NOT SEEK MEDICAL ATTENTION. DRIVE IS CURRENTLY INVESTIGATING THE INCIDENT, INCLUDING ATTEMPTING TO RETRIEVE THE PRODUCT AND INSPECT IT, AND WILL FILE AN UPDATE IF ADDITIONAL INFORMATION BECOMES AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1785090 DRIVE CANE IPS COM-DA HEALTHCARE CO.,LTD 10381BLK-1 00822383224916

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR Male