BEUDAMED
    FDA Adverse Event Summary report: N

    DAILY ACTIVITY ASSIST DEVICES

    MDR report key: 3163519 · Received June 11, 2013

    Report

    Report Number
    1531186-2013-02550
    Date Received
    June 11, 2013
    Date of Event
    March 14, 2013
    Report Date
    May 14, 2013
    Manufacturer
    POPULAR PLASTICS
    Product Code
    IKX
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    PATIENT FAMILY MEMBER OR FRIEND

    Narratives

    Description of Event or Problem · 1

    END-USER - HUSBAND STATES THE SEAT HAS DEVELOPED A THIN CRACK THAT IS LONG ENOUGH FOR THE UNIT TO BE FOLDED. END-USER STATES THIS HAPPENED AROUND TWO MONTHS AGO. THIS ISSUE WAS BROUGHT TO LIGHT UPON GAINING INFORMATION FOR FILE (B)(4), WHICH ARE FAILURE OF THIS CHAIR'S REPLACEMENT. END-USER WAS PREPPING FOR SURGERY AT THE TIME THE CRACK DEVELOPED, POSSIBLY CONTRIBUTING TO THIS FAILURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    263904 DAILY ACTIVITY ASSIST DEVICES 890.5050 IKX POPULAR PLASTICS 9780

    Patients

    Seq Age Sex Outcome Treatment
    1 Other