BEUDAMED
    FDA Adverse Event Summary report: N

    GUARDIAN

    MDR report key: 776598 · Received August 31, 2006

    Report

    Report Number
    1034630-2006-00035
    Date Received
    August 31, 2006
    Date of Event
    August 2, 2006
    Report Date
    August 31, 2006
    Manufacturer
    (MARS PRO)
    Product Code
    IKX
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Description of Event or Problem · 1

    THE PATIENT JUST STARTED TO USE THE BENCH AND WHEN HE TRANSFERRED ONTO THE UNIT ONE OF THE LEGS BENT. PATIENT NOT INJURED. SUNRISE HAS REQUESTED THE UNIT BE RETURNED FOR EVALUATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 GUARDIAN TRANSFERBENCH PADDED IKX (MARS PRO) 98013A UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 55 YR