BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INNOVATIVE PRODUCTS UNLIMITED, INC.

    MDR report key: 1872172 · Received October 13, 2010

    Report

    Report Number
    1833497-2010-00011
    Event Type
    Malfunction
    Date Received
    October 13, 2010
    Date of Event
    September 21, 2010
    Report Date
    October 13, 2010
    Manufacturer
    INNOVATIVE PRODUCTS UNLIMITED, INC.
    Product Code
    INN
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    AFTER TALKING WITH FACILITY, IT WAS STATED THAT THE PIPE BROKE FREE FROM THE FITTING SOCKETS IN THREE PLACES. SENT A NEW CHAIR TO THE FACILITY AND WILL GET THE BROKEN CHAIR BACK, WHICH HASN'T ARRIVED YET. WE WILL INSPECT THE CHAIR AND FOLLOW UP WITH ADDITIONAL INFO IF ANY IS FOUND.

    Description of Event or Problem · 1

    A RESIDENT WAS IN A SHOWER CHAIR AND HAD JUST COMPLETED HER SHOWER WHEN THE CHAIR COLLAPSED 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. SC9211

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Hospitalization