BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DRIVE

    MDR report key: 17257963 · Received July 5, 2023

    Report

    Report Number
    3014644996-2023-00005
    Event Type
    Malfunction
    Date Received
    July 5, 2023
    Report Date
    July 4, 2023
    Manufacturer
    COM-DA HEALTHCARE CO.,LTD
    Product Code
    IPS
    UDI-DI
    00822383571041
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 0

    DRIVE DEVILBISS HEALTHCARE WAS NOTIFIED OF A COMPLAINT REGARDING A CANE BY AN END USER, WHO STATED THAT THE "BOTTOM PORTION OF THE CANE BROKE" AND SHE FELL. THERE WAS NO REPORT OR EVIDENCE OF ILLNESS, INJURY OR MEDICAL TREATMENT ASSOCIATED WITH THE COMPLAINT. 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
    418872 DRIVE CANE IPS COM-DA HEALTHCARE CO.,LTD HCANE-BL-C2 00822383571041

    Patients

    Seq Age Sex Outcome Treatment
    1 Female