BEUDAMED
    FDA Adverse Event Summary report: N

    MECHANICAL (MANUAL) WHEELCHAIR

    MDR report key: 3083527 · Received April 29, 2013

    Report

    Report Number
    1531186-2013-01806
    Date Received
    April 29, 2013
    Date of Event
    April 2, 2013
    Report Date
    April 2, 2013
    Manufacturer
    JUMAO MEDICAL EQUIPMENT
    Product Code
    IOR
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4) IT WAS REPORTED BY THE CONSUMER THAT THE V18RLR CUSTOM MECHANICAL WHEELCHAIR ARMS WOULD NOT STAY LATCHED, AND IT HAD MISSING COMPONENTS. ADDITIONALLY, IT WAS REPORTED THAT THE UPHOLSTERY RIPPED ON THE SIDE WHICH CAUSED HER TO FALL BACKWARDS. MEDICAL EMERGENCY ATTENTION WAS SOUGHT. SHOULD WE RECEIVE ADDITIONAL INFORMATION, THIS FILE WILL BE REVISED, AND A SUPPLEMENTAL REPORT WILL BE SUBMITTED. ONLY ONE MDR REPORT WILL BE SUBMITTED FOR THIS EVENT, ALTHOUGH TWO DIFFERENT COMPLAINTS WERE CREATED BECAUSE OF DIFFERENT PARTS NEEDED TO REPAIR THE UNIT, AND THE FILE NUMBERS ARE THE FOLLOWING: (B)(4).

    Description of Event or Problem · 1

    (B)(4) IT WAS REPORTED BY THE CONSUMER THAT THE V18RLR CUSTOM MECHANICAL WHEELCHAIR ARMS WOULD NOT STAY LATCHED, AND IT HAD MISSING COMPONENTS. ADDITIONALLY, IT WAS REPORTED THAT THE UPHOLSTERY RIPPED ON THE SIDE WHICH CAUSED HER TO FALL BACKWARDS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    184613 MECHANICAL (MANUAL) WHEELCHAIR 890.3850 IOR JUMAO MEDICAL EQUIPMENT V18RLR

    Patients

    Seq Age Sex Outcome Treatment
    1 24 Other