BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MECHANICAL (MANUAL) WHEELCHAIR

    MDR report key: 4060912 · Received September 4, 2014

    Report

    Report Number
    9616091-2014-01750
    Event Type
    Malfunction
    Date Received
    September 4, 2014
    Date of Event
    August 7, 2014
    Report Date
    August 11, 2014
    Manufacturer
    INVAMEX
    Product Code
    IOR
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KY, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    END USER STATED THE FRONT LEFT CASTER BROKE. THE SPOKE BROKE OUT OF THE CASTER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    541680 MECHANICAL (MANUAL) WHEELCHAIR 890.3850 IOR INVAMEX TRSX58FB

    Patients

    Seq Age Sex Outcome Treatment
    1 32 Other