BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MECHANICAL (MANUAL) WHEELCHAIR

    MDR report key: 3232886 · Received July 18, 2013

    Report

    Report Number
    9616091-2013-01237
    Event Type
    Malfunction
    Date Received
    July 18, 2013
    Date of Event
    June 26, 2013
    Report Date
    June 26, 2013
    Manufacturer
    INVAMEX
    Product Code
    IOR
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CT, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    THE PROVIDER STATED THE SEAT UPHOLSTERY IS SAGGING AND COMING LOOSE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    334205 MECHANICAL (MANUAL) WHEELCHAIR 890.3850 IOR INVAMEX T4

    Patients

    Seq Age Sex Outcome Treatment
    1 Other