BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GUARDIAN

    MDR report key: 696498 · Received April 5, 2006

    Report

    Report Number
    1034630-2006-00016
    Event Type
    Malfunction
    Date Received
    April 5, 2006
    Date of Event
    March 15, 2006
    Report Date
    April 5, 2006
    Manufacturer
    R POON
    Product Code
    INN
    Product Problem
    Yes
    Report Source
    Distributor report
    Reporter Location
    OH, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Description of Event or Problem · 1

    THE END USER, WHO IS UNDER WEIGHT CAPACITY OF UNIT, REPORTED AN INJURY. CUSTOMER HAS INSPECTED AND NOTED THAT ONE OF THE FOUR LEGS HAS SEPERATED COMPLETELY AT A POINT ROUGHTLY 2 INCHES FROM THE CENTER CROSS BRACE. SUNRISE HAS REQUESTED THE UNIT BE RETURNED FOR EVALUATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 GUARDIAN CHARI EZ-CARE W/ BACK INN R POON 30400-4 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 *