BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MYON SWINGAWAY WHEELCHAIR

    MDR report key: 9818105 · Received March 11, 2020

    Report

    Report Number
    9616091-2020-00011
    Event Type
    Injury
    Date Received
    March 11, 2020
    Report Date
    February 14, 2020
    Manufacturer
    INVAMEX MANUFACTURING
    Product Code
    IOR
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 1

    INVACARE WAS MADE AWARE OF THIS EVENT THAT OCCURRED IN (B)(6, INVOLVING A REA SPIREA WHEELCHAIR WHICH WAS MANUFACTURE BY INVACARE (B)(4). THIS RECORD WAS CREATED DUE TO THE MYON WHEELCHAIR, MADE AT INVACARE OWNED INVAMEX AND SOLD IN THE US HAS BEEN DETERMINED TO BE SIMILAR IN DESIGN. THE REA SPIREA WHEELCHAIR HAS AN ALBER VIAMOBIL ATTACHED TO THE CHAIR WHICH, IS A PUSH AND BRAKE AID THAT IS NOT OFFERED IN THE US. THIS MALFUNCTION IS CONSISTENT WITH SOMEONE DRIVING THE CHAIR IT TOO FAST INTO A CURB. AN EVALUATION OF THE CHAIR HAS NOT BEEN COMPLETED AS OF THE DATE OF THIS FILING.

    Description of Event or Problem · 1

    THE STAFF WAS WALKING WITH THE PATIENT, OUTSIDE WHEN THE FRONT FORK MOUNT BROKE OFF ON THE RIGHT SIDE. THE PATIENT FELL OUT OF THE WHEELCHAIR, GOT A CUT ABOVE THEIR LEFT EYE, AND HAS PAIN IN THEIR LEFT HIP. THE END-USER WAS TAKEN TO THE HOSPITAL WHERE THEY RECEIVED STITCHES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    282786 MYON SWINGAWAY WHEELCHAIR WHEELCHAIR, MECHANICAL IOR INVAMEX MANUFACTURING NA:MYON

    Patients

    Seq Age Sex Outcome Treatment
    1 Other