BEUDAMED
    FDA Adverse Event Summary report: N

    DAILY ACTIVITY ASSIST DEVICES

    MDR report key: 2862837 · Received December 10, 2012

    Report

    Report Number
    1531186-2012-01679
    Date Received
    December 10, 2012
    Report Date
    December 7, 2012
    Manufacturer
    PINGHU WEIFENG MATERIAL TECHNOLOGY
    Product Code
    IKX
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Description of Event or Problem · 1

    OB (B)(6) - IT WAS REPORTED BY THE CONSUMER THAT THE 96-2 SHOWER CHAIR LEGS COLLAPSED IN SHOWER DURING USE. THERE WAS NO PATIENT INJURY REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 DAILY ACTIVITY ASSIST DEVICES 890.5050 IKX PINGHU WEIFENG MATERIAL TECHNOLOGY 96-2

    Patients

    Seq Age Sex Outcome Treatment
    1 45 Other