BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DRIVE

    MDR report key: 17255541 · Received July 5, 2023

    Report

    Report Number
    3014644996-2023-00006
    Event Type
    Malfunction
    Date Received
    July 5, 2023
    Report Date
    July 4, 2023
    Manufacturer
    COM-DA HEALTHCARE CO.,LTD
    Product Code
    IPS
    UDI-DI
    00754021210237
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NV, 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 "[CANE] BASE IS NOT LARGE ENOUGH" AND THAT SHE FELL TO THE GROUND AND SUSTAINED BRUISING TO HER HIP WHILE USING IT, BUT DID NOT RECEIVE ANY MEDICAL TREATMENT. THE END USER SPECIFICALLY STATED THAT "THERE IS NOTHING WRONG WITH THE CANE EXCEPT SHE DOES NOT FEEL THE BASE IS BIG ENOUGH." DRIVE WILL CONTINUE TO MONITOR COMPLAINTS FOR ANY RELATED TRENDS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1786876 DRIVE CANE IPS COM-DA HEALTHCARE CO.,LTD 731-852 00754021210237

    Patients

    Seq Age Sex Outcome Treatment
    1 75 YR Female