BEUDAMED
    FDA Adverse Event Summary report: N

    POWERED WHEELCHAIR

    MDR report key: 3943835 · Received July 18, 2014

    Report

    Report Number
    3008262382-2014-00320
    Date Received
    July 18, 2014
    Date of Event
    May 1, 2014
    Report Date
    June 24, 2014
    Manufacturer
    INVACARE REHABILITATION EQUIP
    Product Code
    ITI
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Description of Event or Problem · 1

    PER END USER THAT SHE WENT TO SIT THE CHAIR AND STATED THE UNIT WAS NOT THERE AND THAT THE CHAIR MUST OF MOVED ON ITS OWN CAUSING THE END USER FALL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    421441 POWERED WHEELCHAIR 890.3860 ITI INVACARE REHABILITATION EQUIP M41SRB

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention