BEUDAMED
    FDA Adverse Event Summary report: N

    DAILY ACTIVITY ASSIST DEVICES

    MDR report key: 2832739 · Received November 14, 2012

    Report

    Report Number
    1525712-2012-02160
    Date Received
    November 14, 2012
    Report Date
    November 9, 2012
    Manufacturer
    PINGHU WEIFENG MATERIAL TECHNOLOGY
    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

    (B)(4). NO SERIOUS INJURY ALLEGED. MALFUNCTION ALLEGED. DAUGHTER STATES FOR HER MOM THAT SHE IS HAVING ISSUES WITH HER SHOWER CHAIR. SHE SAYS THAT THE TWO BACK LEGS AND THE LEFT FRONT KEEP BOWING AWAY FROM THE CHAIR. SHE REPORTS THAT THIS IS THE THIRD CHAIR HER MOTHER AS HAD AND ALL HAVE HAD THE SAME ISSUE. MDR FILED.

    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 60 Other