BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MECHANICAL (MANUAL) WHEELCHAIR

    MDR report key: 3000627 · Received March 12, 2013

    Report

    Report Number
    9616091-2013-00429
    Event Type
    Malfunction
    Date Received
    March 12, 2013
    Report Date
    February 14, 2013
    Manufacturer
    INVAMEX
    Product Code
    IOR
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    (B)(4). IT WAS REPORTED BY THE CONSUMER THAT THE TRSX5RC MECHANICAL WHEELCHAIR LEGREST PLATE PAD CRACKED BETWEEN THE TWO SCREW HOLES CAUSING THE LEFT CALF PAD TO FALL OFF THE RIGGING. THERE WAS NO PATIENT INJURY REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    102945 MECHANICAL (MANUAL) WHEELCHAIR 890.3850 IOR INVAMEX TRSX5RC

    Patients

    Seq Age Sex Outcome Treatment
    1 Other