BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    POWERED WHEELCHAIR

    MDR report key: 3163537 · Received June 11, 2013

    Report

    Report Number
    3004493922-2013-01249
    Event Type
    Malfunction
    Date Received
    June 11, 2013
    Report Date
    May 14, 2013
    Manufacturer
    INVACARE SUZHOU
    Product Code
    ITI
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    ENSUSER STATED SOCKET SCREW IN BACK OF FOOTBOARD KEEPS GETTING LOOSE. CHAIR IS M41. NO S/N AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    264657 POWERED WHEELCHAIR 890.3860 ITI INVACARE SUZHOU M41

    Patients

    Seq Age Sex Outcome Treatment
    1 85 Other