BEUDAMED
    FDA Adverse Event Summary report: N

    DAILY ACTIVITY ASSIST DEVICES

    MDR report key: 2973247 · Received February 21, 2013

    Report

    Report Number
    1531186-2013-00703
    Date Received
    February 21, 2013
    Date of Event
    January 22, 2013
    Report Date
    February 21, 2013
    Manufacturer
    PINGHU WEIFENG MATERIAL TECHNOLOGY
    Product Code
    IKX
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AL, US
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Description of Event or Problem · 1

    (B)(4). NO SERIOUS INJURY ALLEGED. MALFUNCTION ALLEGED. PROVIDER STATES LEGS ON BENCH SPREAD OUT CAUSING END USER TO FALL ON HIS BACK IN THE SHOWER. HE WAS GETTING SHOWERED TO GO INTO SURGERY AND FELL OFF THE SEAT. THE SEAT ITSELF DID NOT CRACK. NOT SURE INJURIES ARE FROM FALL OR SURGERY. MDR FILED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    76268 DAILY ACTIVITY ASSIST DEVICES 890.5050 IKX PINGHU WEIFENG MATERIAL TECHNOLOGY 91-2

    Patients

    Seq Age Sex Outcome Treatment
    1 72 Other