BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INNOVATIVE PRODUCTS UNLIMITED, INC

    MDR report key: 829852 · Received March 16, 2007

    Report

    Report Number
    1833497-2007-00003
    Event Type
    Injury
    Date Received
    March 16, 2007
    Date of Event
    January 28, 2007
    Report Date
    March 14, 2007
    Manufacturer
    INNOVATIVE PRODUCTS UNLIMITED, INC.
    Product Code
    FPO
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AL, US
    Reporter Occupation
    INVALID DATA

    Narratives

    Additional Manufacturer Narrative · 1

    USER FACILITY FAXED INCIDENT REPORT TO MFR ON 02/20/2007. MFR HAS TRIED TO INVESTIGATE FURTHER, BUT USER FACILITY WILL NOT TAKE ANY CALLS PERTAINING TO THIS EVENT. MFR IS TRYING TO OBTAIN A COPY OF THE STATES HEALTH DEPARTMENTS INVESTIGATION REPORT AT THIS TIME. NO PROBLEM WITH DEVICE REPORTED.

    Description of Event or Problem · 1

    RESIDENT FELL OFF SHOWER BED STRECHER IN THE SHOWER ROOM. CNA WAS GOING TO CLEAN HER UP, BECAUSE RESIDENT HAD A BM. RESIDENT HAD A LACERATION TO THE FOREHEAD, BRUISE ON HER LEFT ELBOW AND A TEAR ON HER RIGHT LOWER LEG. NO PROBLEMS WITH DEVICE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INNOVATIVE PRODUCTS UNLIMITED, INC SHOWER GURNEY FPO INNOVATIVE PRODUCTS UNLIMITED, INC. TSG700 *

    Patients

    Seq Age Sex Outcome Treatment
    1 * Hospitalization