BEUDAMED
    FDA Adverse Event Other Summary report: N

    GUARDIAN SELECT COMMODE

    MDR report key: 1051797 · Received May 22, 2008

    Report

    Report Number
    3006459587-2008-00012
    Event Type
    Other
    Date Received
    May 22, 2008
    Date of Event
    July 30, 2007
    Report Date
    April 17, 2008
    Product Code
    INB
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NH, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THIS INFORMATION WAS RECEIVED FROM THE US CPSC ON 02/29/08. THE COMMODE WAS NOT RETURNED FOR EVALUATION SO, NO CONCLUSION CAN BE DRAWN WITH REGARDS TO THE CAUSE OF THE INCIDENT.

    Description of Event or Problem · 1

    THE END USER RECEIVED A CUT TO BACK OF HER LEG FROM THE CLAMPS USED TO HOLD THE UNIT TO THE TOILET.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 GUARDIAN SELECT COMMODE ELEVATED TOILET SEAT INB UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 86 YR Other