BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MECHANICAL (MANUAL) WHEELCHAIR

    MDR report key: 2930667 · Received January 28, 2013

    Report

    Report Number
    9616091-2013-00126
    Event Type
    Malfunction
    Date Received
    January 28, 2013
    Report Date
    January 25, 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

    A FACILITY HAS REPORTED TO THIS DEALER THAT THE FOOTPLATE IS BREAKING OFF THE FRONT RIGGINGS. DEVICE HAS SINCE BEEN REPLACED. THE FACILITY HAD USED THE MANUAL WHEELCHAIR FOR APPROXIMATELY 6 TO 12 MONTHS. NO INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    37258 MECHANICAL (MANUAL) WHEELCHAIR 890.3850 IOR INVAMEX UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Other