BEUDAMED
    FDA Adverse Event Death Summary report: N

    MEDICAL GRADE OXYGEN CYLINDERS

    MDR report key: 11723435 · Received April 23, 2021

    Report

    Report Number
    MW5100958
    Event Type
    Death
    Date Received
    April 23, 2021
    Date of Event
    October 20, 2020
    Report Date
    April 21, 2021
    Manufacturer
    GRACE HEALTHCARE MEDICAL
    Product Code
    CAN
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    MS, US
    Reporter Occupation
    PATIENT FAMILY MEMBER OR FRIEND

    Narratives

    Description of Event or Problem · 1

    HUSBAND WAS ON OXYGEN FROM GRACE HEALTHCARE MEDICAL SINCE 2017 THE MORNING OF (B)(6) HE STARTED HAVING CONVULSIONS WHILE ON THE OXYGEN. GOT A LETTER FROM THEM ON 4/20/2021 STATING A VOLUNTARY RECALL ON MEDICAL GRADE OXYGEN. HE PASSED AWAY ON (B)(6) 2020. I DO NOT HAVE THE PRODUCT ANYMORE. WHEN MY HUSBAND PASSED AWAY I CALLED THEM TO COME PICK UP THE TANKS BUT HE WAS ON THE OXYGEN 24/7. FDA SAFETY REPORT ID#: (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    614015 MEDICAL GRADE OXYGEN CYLINDERS REGULATOR, PRESSURE, GAS CYLINDER CAN GRACE HEALTHCARE MEDICAL

    Patients

    Seq Age Sex Outcome Treatment
    1 61 YR Death| H