BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MECHANICAL (MANUAL) WHEELCHAIR

    MDR report key: 3062113 · Received April 16, 2013

    Report

    Report Number
    1525712-2013-02911
    Event Type
    Malfunction
    Date Received
    April 16, 2013
    Report Date
    March 20, 2013
    Manufacturer
    INVAMEX
    Product Code
    IOR
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4) ISSUED MFR. REPORT # 1525712-2013-02911 INDICTING THE BRAND NAME AS POWERED WHEELCHAIR, DEVICE IS A MECHANICAL (MANUAL) WHEELCHAIR, COMMON DEVICE NAME AS 890.3860, ACTUAL IS 890.3850, PRODUCT CODE AS ITI, ACTUAL IS IOR, MANUFACTURER AS UNKNOWN, ACTUAL MANUFACTURER IS INVAMEX AND THE MODEL IS AN UNKNOWN 9000 SERIES. THE FDA REGISTRATION NUMBER WAS REPORTED AS (B)(4) WHEN IT IS ACTUALLY (B)(4).

    Description of Event or Problem · 1

    PER PROVIDER A PART SNAPPED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    162791 MECHANICAL (MANUAL) WHEELCHAIR 890.3850 IOR INVAMEX UNKNOWN 9000 SERIES

    Patients

    Seq Age Sex Outcome Treatment
    1 Other