BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CHAD THERAPEUTICS

    MDR report key: 4922505 · Received July 17, 2015

    Report

    Report Number
    2438477-2015-00019
    Event Type
    Malfunction
    Date Received
    July 17, 2015
    Date of Event
    June 19, 2013
    Report Date
    June 17, 2015
    Manufacturer
    INOVO, INC
    Product Code
    NFB
    Product Problem
    Yes
    Report Source
    Distributor report
    Reporter Location
    PA, US
    Reporter Occupation
    ATTORNEY

    Narratives

    Description of Event or Problem · 1

    DRIVE MEDICAL RECEIVED NOTICE FROM AN ATTORNEY OF AN INCIDENT INVOLVING AN OXYGEN CONSERVER, A DEVICE DISTRIBUTED BY A DRIVE COMPANY. THE DEVICE ALLEGEDLY CONTAINED A DEFECTIVE SEAL AND/OR CONTAMINATES WITHIN THE PRODUCT THAT CAUSED OXYGEN TO LEAK, RESULTING IN EXTENSIVE DAMAGE TO THE PLAINTIFF'S HOME. THIS REPORT IS BASED ON INFORMATION PROVIDED BY THE ATTORNEY AND HEALTHCARE PROVIDER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    464937 CHAD THERAPEUTICS OXYGEN CONSERVER NFB INOVO, INC OM-411A

    Patients

    Seq Age Sex Outcome Treatment
    1