BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INNOVATIVE PRODUCTS UNLIMITED, INC.

    MDR report key: 807497 · Received January 9, 2007

    Report

    Report Number
    1833497-2007-00001
    Event Type
    Malfunction
    Date Received
    January 9, 2007
    Date of Event
    December 14, 2006
    Report Date
    January 9, 2007
    Manufacturer
    INNOVATIVE PRODUCTS UNLIMITED, INC.
    Product Code
    INM
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    AFTER EVAL OF DEVICE, MFR OF THE DEVICE DETERMINED THAT USER FACILITY HAD MODIFIED THE LEGS OF THE DEVICE. MFR DETERMINED THAT USER FACILITY HAD USED A COMMERCIAL PLUMBING PIPE AND GLUE TO REPLACE THE LEGS OF THE CHAIR WHICH CONTRIBUTED TO THE EVENT. AFTER REVIEWING THE USER FACILITIES INCIDENT REPORT AND EVAL OF DEVICE, THE DEVICE FAILED AT THE POINT THAT THE USER FACILITY HAD MODIFIED THE DEVICE.

    Description of Event or Problem · 1

    CHAIR FELL APART CAUSING RESIDENT TO FALL AND RECEIVE A BUMP ON RIGHT SIDE BACK OF HEAD. RESIDENT ALSO HAD SCRAPES ON RIGHT SHOULDER AND BACK OF RIGHT ARM. USER FACILITY INCIDENT REPORT STATES: THE FRONT RIGHT LEG SUPPORT LOOKS LIKE IT PULLED OUT OF THE FRONT LEG, THEN THE BACK LEG FOLDED UNDER THE CHAIR AND OTHER JOINTS BROKE FROM THE STRESS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INNOVATIVE PRODUCTS UNLIMITED, INC. SHOWER CHAIR INM INNOVATIVE PRODUCTS UNLIMITED, INC. SC100 *

    Patients

    Seq Age Sex Outcome Treatment
    1 *