BEUDAMED
    FDA Adverse Event Summary report: N

    INVACARE MEDICAL

    MDR report key: 4635162 · Received March 18, 2015

    Report

    Report Number
    3004766495-2015-00043
    Date Received
    March 18, 2015
    Date of Event
    October 12, 2014
    Report Date
    March 8, 2015
    Manufacturer
    DANYANG JUMAO HEALTHCARE EQUIPMENT CO.,LTD.
    Product Code
    IOR
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    TRAINING FCQ FULLY INSPECT ALL WHEELCHAIRS, ESPECIALLY FUNCTIONAL ISSUES. RESPONSIBLE PERSON: (B)(4). TRAINING ASSEMBLY WORKERS, FOLLOWING SOP. TRANSPORTATION PROTECTION SHOULD BE PROPERLY APPLIED. RESPONSIBLE PERSON: (B)(4).

    Description of Event or Problem · 1

    CUSTOMER STATES THE WHEELCHAIR VEERS TO THE RIGHT AND THE LEFT WHEEL IS TILTED INWARD.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    185958 INVACARE MEDICAL MECHANICAL (MANUAL) WHEELCHAIR IOR DANYANG JUMAO HEALTHCARE EQUIPMENT CO.,LTD. TREX28R

    Patients

    Seq Age Sex Outcome Treatment
    1