BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MECHANICAL (MANUAL) WHEELCHAIR

    MDR report key: 4103073 · Received September 19, 2014

    Report

    Report Number
    9616091-2014-01931
    Event Type
    Malfunction
    Date Received
    September 19, 2014
    Report Date
    August 26, 2014
    Manufacturer
    INVAMEX
    Product Code
    IOR
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Description of Event or Problem · 1

    PROVIDER STATES THAT THE FRONT CASTERS ARE VERY WOBBLY ON THIS UNIT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    582646 MECHANICAL (MANUAL) WHEELCHAIR 890.3850 IOR INVAMEX TRSX58FBP

    Patients

    Seq Age Sex Outcome Treatment
    1 Other