BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INNOVATIVE PRODUCTS UNLIMITED, INC.

    MDR report key: 1698922 · Received May 21, 2010

    Report

    Report Number
    1833497-2010-00008
    Event Type
    Malfunction
    Date Received
    May 21, 2010
    Date of Event
    April 23, 2010
    Report Date
    May 21, 2010
    Manufacturer
    INNOVATIVE PRODUCTS UNLIMITED, INC.
    Product Code
    INN
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    WHILE MOVING THE RESIDENT IN THE SHOWER CHAIR INTO THE SHOWER, THE CHAIR TIPPED BACKWARDS. STAFF MEMBER PUT LEG BEHIND CHAIR TO BREAK FALL. THE CHAIR BROKE AT THE BACKREST. THE RESIDENT AND STAFF FELL TO THE FLOOR. NO INJURY TO RESIDENT. STAFF SUSTAINED INJURY TO LEFT LEG. WE WERE NOT ABLE TO GET THE CHAIR BACK FOR EVALUATION AND THE INFORMATION ABOVE IS ALL WE HAVE ON THIS INCIDENT. SENT NEW CHAIR TO FACILITY TO REPLACE THE BROKEN ONE.

    Description of Event or Problem · 1

    WHILE MOVING THE RESIDENT IN THE SHOWER CHAIR INTO THE SHOWER, THE CHAIR TIPPED BACKWARDS. STAFF MEMBER PUT LEG BEHIND CHAIR TO BREAK FALL. THE CHAIR BROKE AT THE BACKREST. THE RESIDENT AND STAFF FELL TO THE FLOOR. NO INJURY TO RESIDENT. STAFF SUSTAINED INJURY TO LEFT LEG.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INNOVATIVE PRODUCTS UNLIMITED, INC. SHOWER CHAIR INN INNOVATIVE PRODUCTS UNLIMITED, INC. ESC19

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK