BEUDAMED
    FDA Adverse Event Death Summary report: N

    MYON SWINGAWAY WHEELCHAIR

    MDR report key: 9494571 · Received December 19, 2019

    Report

    Report Number
    9616091-2019-00032
    Event Type
    Death
    Date Received
    December 19, 2019
    Date of Event
    August 3, 2018
    Report Date
    November 22, 2019
    Manufacturer
    INVAMEX MANUFACTURING
    Product Code
    IOR
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 1

    INVACARE WAS MADE AWARE OF THIS EVENT WHICH OCCURRED IN THE UNITED KINGDOM INVOLVING AN REA AZALEA WHEELCHAIR WHICH WAS MANUFACTURED BY INVACARE FRANCE. INVACARE IS FILING THIS REPORT BECAUSE THE MYON WHEELCHAIR MADE AT INVACARE OWNED INVAMEX AND SOLD IN THE U.S. HAS BEEN DETERMINED TO BE SIMILAR IN DESIGN TO THE ACTION 3.

    Description of Event or Problem · 1

    THE PATIENT WAS BEING TRANSPORTED IN A REA AZALEA WHEELCHAIR, ON A COMMUNITY TRANSPORT BUS. SHE SLID FORWARD OUT OF THE WHEELCHAIR, BREAKING BOTH LEGS. SHE WAS NOT WEARING THE FITTED LAP BELT. COMPLICATIONS DURING HOSPITAL STAY LEADING TO DEATH.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1288063 MYON SWINGAWAY WHEELCHAIR WHEELCHAIR, MECHANICAL IOR INVAMEX MANUFACTURING NA:MYON

    Patients

    Seq Age Sex Outcome Treatment
    1 Death| H| O