BEUDAMED
    FDA Adverse Event Summary report: N

    INVACARE MEDICAL

    MDR report key: 4635125 · Received March 18, 2015

    Report

    Report Number
    3004766495-2015-00056
    Date Received
    March 18, 2015
    Report Date
    March 16, 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

    THIS ISSUE RELATED MODEL NO. IS TRSX52FBP, AND THE SERIAL NO. IS (B)(4), WE HAVE CHECKED OUR DHR AND MFR HISTORY, THIS ALLEGED PRODUCTION IS NOT IN OUR LIST, MEANS THIS WHEELCHAIR IS NOT MANUFACTURED BY OUR FIRM, I THINK THIS IS DUE TO DEALER MIXING UP WHEELCHAIRS FROM DIFFERENT MFRS.

    Description of Event or Problem · 1

    DEALER ADVISED TWO SEAT RAILS WILL NOT OPEN FULLY OPEN DUE TO BEING BENT AT WELD CAUSING SEAT TO SAG OUT OF THE BOX.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    185974 INVACARE MEDICAL WHEELCHAIR, MECHANICAL (MANUAL) IOR DANYANG JUMAO HEALTHCARE EQUIPMENT CO.,LTD. TRSX52FBP

    Patients

    Seq Age Sex Outcome Treatment
    1 Other