BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    POWERED WHEELCHAIR

    MDR report key: 3935212 · Received July 15, 2014

    Report

    Report Number
    9616091-2014-01206
    Event Type
    Malfunction
    Date Received
    July 15, 2014
    Date of Event
    June 10, 2014
    Report Date
    June 10, 2014
    Manufacturer
    INVAMEX
    Product Code
    ITI
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Description of Event or Problem · 1

    DEALER ADVISED FRONT LEFT CASTER TIRE CAME OFF THE RIM. NO INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    412469 POWERED WHEELCHAIR 890.3860 ITI INVAMEX ATM1816R

    Patients

    Seq Age Sex Outcome Treatment
    1 Other