BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INNOVATIVE PRODUCTS UNLIMITED, INC.

    MDR report key: 1547898 · Received November 19, 2009

    Report

    Report Number
    1833497-2009-00004
    Event Type
    Malfunction
    Date Received
    November 19, 2009
    Report Date
    November 19, 2009
    Manufacturer
    INNOVATIVE PRODUCTS UNLIMITED, INC.
    Product Code
    INN
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KY, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    WE RECEIVED A REPORT STATING THAT A RESIDENT WAS IN A SHOWER CHAIR WHEN THE FRONT SUPPORT BAR CAME LOOSE FROM FITTING CAUSING THE RESIDENT TO FALL. CONTACTED THE DIRECTOR OF MAINTENANCE WHO SAID THE RESIDENT WAS DOING FINE BUT DIDN'T HAVE EXTENSIVE KNOWLEDGE OF WHAT HAPPENED. FACILITY DID NOT RETURN THE CHAIR AND WILL NOT SEND AN INCIDENT REPORT OR SUMMARY OF EVENTS. WITHOUT INSPECTING THE CHAIR AND NO REAL KNOWLEDGE OF WHAT OCCURRED, NO FURTHER ACTION CAN BE TAKEN.

    Description of Event or Problem · 1

    WE RECEIVED A REPORT THAT A RESIDENT WAS IN A SHOWER CHAIR WHEN THE FRONT SUPPORT BAR CAME OUT OF THE FITTING CAUSING THE RESIDENT TO FALL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INNOVATIVE PRODUCTS UNLIMITED, INC. SHOWER CHAIR INN INNOVATIVE PRODUCTS UNLIMITED, INC. SC9200 OS

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK