BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MECHANICAL (MANUAL) WHEELCHAIR

    MDR report key: 2912526 · Received January 12, 2013

    Report

    Report Number
    9616091-2013-00069
    Event Type
    Malfunction
    Date Received
    January 12, 2013
    Report Date
    January 12, 2013
    Manufacturer
    INVAMEX
    Product Code
    IOR
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CT, US
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). NO RMA HAS BEEN INITIATED FOR THIS ISSUE. THE MALFUNCTION HAS NOT BEEN CONFIRMED.

    Description of Event or Problem · 1

    (B)(4). NO SERIOUS INJURY ALLEGED. MALFUNCTION ALLEGED. DEALER ALLEGES THE LEFT BRAKE IS FLOPPING FORWARD AND LOOKS LIKE IT'S SEVERAL YEARS OLD AND VERY WORN. HE SAID WHEN HE DELIVERED IT, IT LOOKED BRAND NEW. MDR FILED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    19424 MECHANICAL (MANUAL) WHEELCHAIR 890.3850 IOR INVAMEX T4

    Patients

    Seq Age Sex Outcome Treatment
    1 Other