BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MECHANICAL (MANUAL) WHEELCHAIR

    MDR report key: 3977124 · Received August 4, 2014

    Report

    Report Number
    9616091-2014-01417
    Event Type
    Malfunction
    Date Received
    August 4, 2014
    Report Date
    June 30, 2014
    Manufacturer
    INVAMEX
    Product Code
    IOR
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    DE, US
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Description of Event or Problem · 1

    THE PROVIDER STATES THE TIRE CAME OFF THE RIM. DUE TO THE EXPOSED RIM, THE PROVIDER STATES THE RIM IS NOW BENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    454132 MECHANICAL (MANUAL) WHEELCHAIR 890.3850 IOR INVAMEX 9XT

    Patients

    Seq Age Sex Outcome Treatment
    1 Other