BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    IPU

    MDR report key: 764952 · Received November 9, 2005

    Report

    Report Number
    1833497-2005-00006
    Event Type
    Malfunction
    Date Received
    November 9, 2005
    Date of Event
    October 25, 2005
    Report Date
    November 2, 2005
    Manufacturer
    INNOVATIVE PRODUCTS UNLIMITED, INC.
    Product Code
    FPO
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    PIPE SEPARATED FROM FITTING. SENT REPAIR PARTS TO USER FACILITY.

    Description of Event or Problem · 1

    CNA SHOWERING RESIDENT STATES WHEN SHE TURNED HIM, HIS WEIGHT AGAINST SIDE RAIL CAUSED IT TO COME APART AT A CONNECTOR, AND RESIDENT SLIPPED OFF STRETCHER AND FELL TO FLOOR. UPON FALLING RESIDENT SUSTAINED A SCALP LACERATION APPROX 2 INCHES IN LENGTH ON TOP OF HEAD. NO OTHER INJURIES WERE NOTED. RESIDENT SENT TO ER FOR EVALUATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 IPU SHOWER/TRANSPORT GURNEY FPO INNOVATIVE PRODUCTS UNLIMITED, INC. TSG500 EL *

    Patients

    Seq Age Sex Outcome Treatment
    1 22 YR Other