BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DAILY ACTIVITY ASSIST DEVICES

    MDR report key: 2143200 · Received June 28, 2011

    Report

    Report Number
    1525712-2011-00299
    Event Type
    Malfunction
    Date Received
    June 28, 2011
    Date of Event
    June 3, 2011
    Report Date
    June 24, 2011
    Manufacturer
    PINGHU WEIFENG MATERIAL TECHNOLOGY
    Product Code
    IKX
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    NO SERIOUS INJURY ALLEGED. MALFUNCTION ALLEGED. ALLEGEDLY, THE CONSUMER SAT DOWN ON THE CHAIR AND THE LEGS BENT. THE CONSUMER IS A (B)(6) MALE. THE CONSUMERS WEIGHT AND HEIGHT ARE NOT KNOWN. THE CONSUMERS MEDICAL CONDITION AND STABILITY FOR USING THE CHAIR ARE UNKNOWN. THE CONSUMERS MEDICATION REGIMEN IS UNKNOWN. THE ENVIRONMENTAL CONDITIONS AND SET UP OF THE CHAIR IN THE SHOWER ARE UNKNOWN. THE AGE OF THE CHAIR IS 4 MONTHS. THE CONDITION OF THE CHAIR IS UNKNOWN.

    Description of Event or Problem · 1

    THE CONSUMER SAT DOWN ON THE CHAIR AND THE LEGS ALLEGEDLY BENT. NO INJURY IS ALLEGED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 DAILY ACTIVITY ASSIST DEVICES 890.5050 IKX PINGHU WEIFENG MATERIAL TECHNOLOGY 91-2 PW110201

    Patients

    Seq Age Sex Outcome Treatment
    1 57 MO