BEUDAMED
    FDA Adverse Event Summary report: N

    MECHANICAL (MANUAL) WHEELCHAIR

    MDR report key: 2862728 · Received December 10, 2012

    Report

    Report Number
    1531186-2012-01657
    Date Received
    December 10, 2012
    Report Date
    December 6, 2012
    Manufacturer
    DANYANG MAXTHAI MEDICAL EQUIPMENT
    Product Code
    IOR
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Description of Event or Problem · 1

    (B)(4) - IT WAS REPORTED BY THE CONSUMER'S CAREGIVER THAT THE (B)(4) MECHANICAL WHEELCHAIR HANDLE GRIP FELL OFF, ALLEGEDLY RESULTING IN THE PATIENT FALLING TO THE FLOOR , AND THE BRAKING MECHANISM WAS NOT FUNCTIONING. THERE WAS NO PATIENT INJURY REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MECHANICAL (MANUAL) WHEELCHAIR 890.3850 IOR DANYANG MAXTHAI MEDICAL EQUIPMENT ALR19HBFR

    Patients

    Seq Age Sex Outcome Treatment
    1 87 Other