BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GUARDIAN EZ-CARE

    MDR report key: 2111828 · Received November 4, 2008

    Report

    Report Number
    3006459587-2008-00075
    Event Type
    Injury
    Date Received
    November 4, 2008
    Date of Event
    May 21, 2008
    Report Date
    November 3, 2008
    Manufacturer
    PROFIT COUNTRY ENTERPRISES LTD.
    Product Code
    INM
    Adverse Event
    Yes
    Report Source
    Distributor report
    Reporter Location
    NC, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    ASSESSMENT IS THAT THE SUPPORTING BACK CLAMP BROKE AWAY FROM THE CHAIR. THE BREAK WAS NOT THE RESULT OF DESIGN OR FAULTY ASSEMBLY. IT APPEARS THE USER WAS USING THE BACK OF THE CHAIR AS A SUPPORT WHEN EXITING THE SHOWER/BATH AREA. THE CHAIR IS DESIGNED TO SUPPORT A PTS DISTRIBUTED WEIGHT. USING THE BACK OF THE CHAIR AS A SUPPORT CAUSED AN OVERLOAD TO THE BACK AND THE SCREWS POPPED AWAY FROM THE ALUMINUM FRAME.

    Description of Event or Problem · 1

    PT FELL (NO INJURY) WHEN BACK REST SCREWS PULLED AWAY FROM THE SHOWER CHAIR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 GUARDIAN EZ-CARE SHOWER CHAIR WITH BACK INM PROFIT COUNTRY ENTERPRISES LTD. 30400-04

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK