BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MECHANICAL (MANUAL) WHEELCHAIR

    MDR report key: 3212079 · Received July 8, 2013

    Report

    Report Number
    9616091-2013-01166
    Event Type
    Malfunction
    Date Received
    July 8, 2013
    Report Date
    June 17, 2013
    Manufacturer
    INVAMEX
    Product Code
    IOR
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Description of Event or Problem · 1

    THE PROVIDER STATED THE FRAME IS BENT. THIS CAUSING BOTH WHEELS TO RUB THE ARMRESTS. THE SCREWS ARE ALSO STRIPPED INSIDE THE RIGHT ARMPAD.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    311175 MECHANICAL (MANUAL) WHEELCHAIR 890.3850 IOR INVAMEX 9SL

    Patients

    Seq Age Sex Outcome Treatment
    1 Other