BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INNOVATIVE PRODUCTS UNLIMITED INC.

    MDR report key: 1359100 · Received April 6, 2009

    Report

    Report Number
    1833497-2009-00001
    Event Type
    Injury
    Date Received
    April 6, 2009
    Date of Event
    March 5, 2009
    Report Date
    April 6, 2009
    Manufacturer
    INNOVATIVE PRODUCTS UNLIMITED, INC.
    Product Code
    INN
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    AFTER RECEIVING THE SHOWER CHAIR BACK FOR INSPECTION, SHOWER CHAIR WAS ALTERED BY FACILITY. SHOWER CHAIR HAD LOWER FITTING REPLACED WITH COMMON PLUMBING FITTING.

    Description of Event or Problem · 1

    SHOWER CHAIR COLLAPSED WITH A RESIDENT IN IT. THERE WAS A CONCERN ABOUT A POSSIBLE BACK OR NECK INJURY, SO FACILITY CALLED PARAMEDICS. THE RESIDENT HAS A FRACTURE TO THE MIDDLE OF HER BACK. ONE OF THE BACK LEGS OF THE CHAIR BENEATH THE "T" FITTING BY THE SEAT IS WHAT BROKE.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization