BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MYON WHEELCHAIR

    MDR report key: 7794157 · Received August 17, 2018

    Report

    Report Number
    9616091-2018-00013
    Event Type
    Injury
    Date Received
    August 17, 2018
    Date of Event
    April 14, 2018
    Report Date
    May 14, 2018
    Manufacturer
    INVAMEX
    Product Code
    IOR
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    INVACARE WAS MADE AWARE OF AN EVENT IN (B)(6) INVOLVING A REA SPIREA 2 MANUAL WHEELCHAIR WHICH WAS MANUFACTURED BY INVACARE (B)(4). INVACARE IS FILING THIS REPORT BECAUSE THE MYON WHEELCHAIR, MADE AT INVACARE OWNED INVAMEX AND SOLD IN THE US HAS BEEN DETERMINED TO BE SIMILAR IN DESIGN TO THE REA SPIREA 2. THE WHEELCHAIR WAS RETURNED TO INVACARE (B)(4) FOR AN EVALUATION. THEY WERE ABLE TO CONFIRM THAT THE WHEELCHAIR IS A REA SPIREA 2, MANUFACTURED IN 2010. THE CHAIR WAS IN POOR CONDITION, DIRTY AND WORN OUT. THE HANDGRIPS WERE ABLE TO BE DETACHED FROM THE BACKREST CANE TUBES. THE DEVICE IS OVER THE ESTIMATED SERVICE LIFE OF FIVE YEARS SPECIFIED IN THE USER MANUAL. IT DOES NOT APPEAR THAT THE SCHEDULED MAINTENANCE WAS FOLLOWED. THE "DAILY PERFORMANCE CHECK" INSTRUCTIONS INCLUDES THE DAILY CHECK OF THE PUSH HANDLES TO ENSURE THAT THE PARTS ARE STILL CURRENTLY ASSEMBLED ON THE WHEELCHAIR. "FAILURE TO COMPLY WITH INSTRUCTIONS GIVEN MAY RESULT IN PERSONAL INJURY AND/OR PRODUCT DAMAGE".

    Description of Event or Problem · 1

    CAREGIVER WAS WALKING DOWNHILL WITH THE USER IN THE CHAIR AND SUDDENLY THE HAND GRIPS CAME OFF. THE USER ROLLED INTO A FENCE AND BROKE HER LEG.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    634996 MYON WHEELCHAIR MECHANICAL (MANUAL) WHEELCHAIR IOR INVAMEX NA:MYON

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention