BEUDAMED
    FDA Adverse Event Summary report: N

    MECHANICAL (MANUAL) WHEELCHAIR

    MDR report key: 3983720 · Received August 6, 2014

    Report

    Report Number
    1531186-2014-03022
    Date Received
    August 6, 2014
    Report Date
    June 26, 2014
    Manufacturer
    JUMAO MEDICAL EQUIPMENT
    Product Code
    IOR
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    PER FACILITY REPRESENTATIVE, THE ARM PADS ARE SHARP AT WHERE THE ARM MEETS THE BASE OF THE ARM CAUSING SKIN ISSUES OF BREAKING DOWN THE SKIN AND CUTS ON THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    461667 MECHANICAL (MANUAL) WHEELCHAIR 890.3850 IOR JUMAO MEDICAL EQUIPMENT V16RFR

    Patients

    Seq Age Sex Outcome Treatment
    1 Other