BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DRIVE

    MDR report key: 17257041 · Received July 5, 2023

    Report

    Report Number
    3014644996-2023-00004
    Event Type
    Malfunction
    Date Received
    July 5, 2023
    Report Date
    July 4, 2023
    Manufacturer
    COM-DA HEALTHCARE CO.,LTD
    Product Code
    ILS
    UDI-DI
    00822383247151
    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 AN INCIDENT INVOLVING A BATH BENCH BY AN END USER, WHO STATED THAT ONE OF THE LEGS OF THE UNIT "SNAPPED OFF," WHICH REPORTEDLY CAUSED HER TO "FALL OVER THE TUB" AND "[INJURE] ENTIRE RIGHT SIDE." THE END USER REPORTEDLY TREATED HER INJURY WITH ICE PACKS AND LIDOCAINE PATCHES. 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
    1930327 DRIVE BATH CHAIR ILS COM-DA HEALTHCARE CO.,LTD RTL12505 00822383247151

    Patients

    Seq Age Sex Outcome Treatment
    1 Female