BEUDAMED
    FDA Adverse Event Injury Summary report: N

    POWERED WHEELCHAIR

    MDR report key: 3521516 · Received December 9, 2013

    Report

    Report Number
    9615350-2013-00019
    Event Type
    Injury
    Date Received
    December 9, 2013
    Date of Event
    November 28, 2010
    Report Date
    December 6, 2013
    Manufacturer
    MOTION CONCEPTS
    Product Code
    ITI
    PMA / PMN Number
    K0212164
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    MOTION CONCEPTS MANUFACTURED AND SOLD A POWERED WHEELCHAIR TO "(B)(4)." ACCORDING TO THE END USER, THE WHEELCHAIR WAS REPAIRED AND MAINTAINED BY "MOBILITY MEDICAL INC" IN THE PAST. MOTION CONCEPTS WAS NOT MADE AWARE OF ANY KIND OF DEFECTS IN THE WHEELCHAIR SINCE JUNE 2009 TILL (B)(4) 2013. AT THIS MOMENT, WE DO NOT HAVE ANY ADDITIONAL DETAILS.

    Description of Event or Problem · 1

    ON (B)(4) 2013, MOTION CONCEPTS WAS MADE AWARE OF THE INCIDENT. LETTER FROM ATTORNEY ALLEGED MALFUNCTION OF POWERED WHEELCHAIR. THE FRONT CASTER OF THE (NON MOTION CONCEPTS) FRONTIER X5 MID WHEEL DRIVER POWER CHAIR MADE CONTACT WITH THE FOOTREST OF MOTION CONCEPTS ULTRA LOW CG TILT/RECLINE/ESR SEATING SYSTEMS, INTERFERING WITH THE ROTATION AND CAUSING THE WHEELCHAIR TO TIP SIDEWAYS AND EJECT THE END USER FROM THE CHAIR. LETTER FURTHER DESCRIBES THAT END USER SUSTAIN PAINFUL INJURIES. ADDITIONAL DETAILS ON INJURIES WERE NOT PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    637918 POWERED WHEELCHAIR 890.3860 ITI MOTION CONCEPTS TRX-ULTRESR (CG)

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Other