BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DRIVE

    MDR report key: 16900307 · Received May 9, 2023

    Report

    Report Number
    3014644996-2023-00003
    Event Type
    Malfunction
    Date Received
    May 9, 2023
    Report Date
    May 9, 2023
    Manufacturer
    COM-DA HEALTHCARE CO.,LTD
    Product Code
    ITJ
    UDI-DI
    00822383240664
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 0

    DRIVE DEVILBISS HEALTHCARE WAS NOTIFIED OF A COMPLAINT REGARDING A ROLLATOR BY AN END USER WHO STATED, "THE BACKREST BRACKET BROKE SENDING HIM TO THE FLOOR." THERE WAS NO REPORT OR EVIDENCE OF ILLNESS, INJURY OR MEDICAL TREATMENT ASSOCIATED WITH THE COMPLAINT. ATTEMPTS WERE MADE TO RETRIEVE THE PRODUCT FOR INVESTIGATION. THE END USER IS UNABLE TO RETURN THE UNIT FOR INVESTIGATION AND DOESN'T HAVE ANYONE WHO CAN ASSIST HIM. A FULL REPLACEMENT WAS SENT TO THE END USER. DRIVE WILL CONTINUE TO MONITOR COMPLAINTS FOR ANY RELATED TRENDS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    578997 DRIVE ROLLATOR ITJ COM-DA HEALTHCARE CO.,LTD R726BK 00822383240664

    Patients

    Seq Age Sex Outcome Treatment
    1 Male