BEUDAMED
    FDA Adverse Event Summary report: N

    DAILY ACTIVITY ASSIST DEVICES

    MDR report key: 3112757 · Received May 14, 2013

    Report

    Report Number
    1531186-2013-02059
    Date Received
    May 14, 2013
    Report Date
    April 18, 2013
    Manufacturer
    PINGHU WEIFENG MATERIAL TECHNOLOGY
    Product Code
    IKX
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). MEDICAL INTERVENTION WAS REQUIRED. END-USER SUSTAINED A HEAD INJURY REQUIRING 6 STAPLES.

    Description of Event or Problem · 1

    PER PROVIDER BRACE BROKE IN CENTER, LEG SNAP.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    212540 DAILY ACTIVITY ASSIST DEVICES 890.5050 IKX PINGHU WEIFENG MATERIAL TECHNOLOGY 91-2

    Patients

    Seq Age Sex Outcome Treatment
    1 Other