BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MECHANICAL (MANUAL) WHEELCHAIR

    MDR report key: 2944760 · Received February 5, 2013

    Report

    Report Number
    9616091-2013-00166
    Event Type
    Malfunction
    Date Received
    February 5, 2013
    Report Date
    February 5, 2013
    Manufacturer
    INVAMEX
    Product Code
    IOR
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). TWO MDR REPORTS WILL BE SUBMITTED FOR THIS PRODUCT, BECAUSE OF DIFFERENT ISSUES WERE REPORTED, AND DIFFERENT PARTS WERE NEEDED. THE FILE NUMBERS ARE THE FOLLOWING: (B)(4) (MDR).

    Description of Event or Problem · 1

    (B)(4). THE DEALER REPORTED THAT THE T422RDA MECHANICAL WHEELCHAIR RIGHT ARM ASSEMBLY MOUNT FRAME WAS BROKEN. THERE WAS NO PATIENT INJURY REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    47818 MECHANICAL (MANUAL) WHEELCHAIR 890.3850 IOR INVAMEX T422RDA

    Patients

    Seq Age Sex Outcome Treatment
    1 Other