BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MECHANICAL (MANUAL) WHEELCHAIR

    MDR report key: 3033988 · Received April 3, 2013

    Report

    Report Number
    9616091-2013-00557
    Event Type
    Malfunction
    Date Received
    April 3, 2013
    Report Date
    March 7, 2013
    Manufacturer
    INVAMEX
    Product Code
    IOR
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VT, US
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Description of Event or Problem · 1

    (B)(4). THE DEALER REPORTED THAT THE TRSX5 MECHANICAL WHEELCHAIR HANDRIM CHROME WAS DETACHING AND CUTTING THE END USER'S HANDS, RESULTING IN MINOR BLEEDING CUTS AND MAKING THE PATIENT TO WEAR BANDAGES. NO MEDICAL ATTENTION WAS SOUGHT. SHOULD WE RECEIVE ADDITIONAL INFORMATION, THIS FILE WILL BE REVISED, AND A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    137078 MECHANICAL (MANUAL) WHEELCHAIR 890.3850 IOR INVAMEX TRSX5

    Patients

    Seq Age Sex Outcome Treatment
    1 Other