BEUDAMED
    FDA Adverse Event Other Summary report: N

    GUARDIAN CHAIR

    MDR report key: 1033066 · Received April 10, 2008

    Report

    Report Number
    3006459587-2008-00008
    Event Type
    Other
    Date Received
    April 10, 2008
    Date of Event
    March 11, 2008
    Report Date
    April 7, 2008
    Product Code
    INM
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS RETURNED DISASSEMBLED AND WITHOUT NECESSARY HARDWARE. FOR EVALUATION THE PRODUCT WAS SET-UP ACCORDING TO USAGE. THERE WERE NO VISIBLE MARKS OR DAMAGES TO THE RETURNED PRODUCT. IT IS UNLIKELY THE PRODUCT FAILED DURING USAGE.

    Description of Event or Problem · 1

    THE END USER OF THE DEVICE STATED THE SHOWER BENCH GAVE WAY, AND HE FELL IN HIS SHOWER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 GUARDIAN CHAIR SHOWER BENCH INM 30403

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Other