BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MECHANICAL (MANUAL) WHEELCHAIR

    MDR report key: 2955963 · Received February 11, 2013

    Report

    Report Number
    9616091-2013-00232
    Event Type
    Malfunction
    Date Received
    February 11, 2013
    Report Date
    February 11, 2013
    Manufacturer
    INVAMEX
    Product Code
    IOR
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WV, US
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). MDR HAS BEEN INITIATED FOR THIS ISSUE. THE MALFUNCTION HAS NOT BEEN CONFIRMED.

    Description of Event or Problem · 1

    PER (B)(6), THE PIVOT LINK PART NUMBER 1110002 FROM STANDARD MANUAL WHEELCHAIR MODEL TRSX5, SERIAL NUMBER (B)(4) BROKE AND IS UNDER WARRANTY NEEDS REPLACED/NO FOLLOW UP REQUIRED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    59780 MECHANICAL (MANUAL) WHEELCHAIR 890.3850 IOR INVAMEX TRSX5

    Patients

    Seq Age Sex Outcome Treatment
    1 Other