BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MECHANICAL (MANUAL) WHEELCHAIR

    MDR report key: 3902001 · Received June 30, 2014

    Report

    Report Number
    9616091-2014-01112
    Event Type
    Malfunction
    Date Received
    June 30, 2014
    Report Date
    May 30, 2014
    Manufacturer
    INVAMEX
    Product Code
    IOR
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Description of Event or Problem · 1

    CUSTOMER STATES THE REAR ARMREST BRACKET THAT WAS WELDED TO THE BACKREST BRACKET IS BROKEN. CUSTOMER STATES THE END USER ROCKS IN HIS SEAT AND IS BREAKING MANY COMPONENTS OVER TIME. NO INJURY OR INCIDENTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    380976 MECHANICAL (MANUAL) WHEELCHAIR 890.3850 IOR INVAMEX SOLARA3G

    Patients

    Seq Age Sex Outcome Treatment
    1 Other