BEUDAMED
    FDA Adverse Event Summary report: N

    MECHANICAL (MANUAL) WHEELCHAIR

    MDR report key: 3230155 · Received July 16, 2013

    Report

    Report Number
    1531186-2013-03188
    Date Received
    July 16, 2013
    Date of Event
    June 24, 2013
    Report Date
    June 26, 2013
    Manufacturer
    CONSMA
    Product Code
    ITJ
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED THE 65851R ROLLATOR COLLAPSED WHEN THE PATIENT SAT DOWN ON THE SEAT. THE PATIENT FELL AND SUSTAINED A SKIN TEAR AND A BLOW TO THE HEAD. THE PATIENT WAS TAKEN TO A NEARBY MEDICAL FACILITY AND A NUMBER OF TESTS WERE DONE TO DETERMINE THE SEVERITY OF THE PATIENT'S INJURIES. NO INFORMATION REGARDING THE TYPE OR RESULTS OF THOSE TESTS WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    329963 MECHANICAL (MANUAL) WHEELCHAIR 890.3850 ITJ CONSMA 65851R

    Patients

    Seq Age Sex Outcome Treatment
    1 78 Other| R