BEUDAMED
    FDA Adverse Event Summary report: N

    DAILY ACTIVITY ASSIST DEVICES

    MDR report key: 3061243 · Received April 16, 2013

    Report

    Report Number
    1531186-2013-01585
    Date Received
    April 16, 2013
    Report Date
    March 20, 2013
    Manufacturer
    PINGHU WEIFENG MATERIAL TECHNOLOGY
    Product Code
    IKX
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    HI, US
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Description of Event or Problem · 1

    POTENTIAL FOR INJURY ASSOCIATED WITH THE CRACKED SEAT PANELS ON FRAME OF A MODEL 98071 TRANSFER BENCH. THIS EVENT COULD LEAD TO PRODUCT INSTABILITY AND CAUSE THE CHAIR TO POSSIBLY REDUCE ITS DESIGNED WEIGHT-BEARING CAPACITY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    161951 DAILY ACTIVITY ASSIST DEVICES 890.5050 IKX PINGHU WEIFENG MATERIAL TECHNOLOGY 98071

    Patients

    Seq Age Sex Outcome Treatment
    1 Other