BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DRIVE

    MDR report key: 17209393 · Received June 27, 2023

    Report

    Report Number
    2438477-2023-00024
    Event Type
    Malfunction
    Date Received
    June 27, 2023
    Report Date
    June 27, 2023
    Manufacturer
    COM-DA HEALTHCARE CO.,LTD
    Product Code
    ILS
    UDI-DI
    00822383247151
    Product Problem
    Yes
    Report Source
    Distributor report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 0

    DRIVE DEVILBISS HEALTHCARE RECEIVED A COMPLAINT INVOLVING A BATH CHAIR FROM AN END USER, WHO STATED THAT "THE LEG OF THE BATH CHAIR COLLAPSED, AND HE SUFFERED A STRAIN IN HIS THIGH MUSCLE." THE END USER DID NOT SEEK ANY MEDICAL TREATMENT. 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
    930664 DRIVE BATH CHAIR ILS COM-DA HEALTHCARE CO.,LTD RTL12505 00822383247151

    Patients

    Seq Age Sex Outcome Treatment
    1 Male