BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GUARDIAN

    MDR report key: 696512 · Received April 5, 2006

    Report

    Report Number
    1034630-2006-00017
    Event Type
    Injury
    Date Received
    April 5, 2006
    Date of Event
    March 6, 2006
    Report Date
    April 5, 2006
    Manufacturer
    JAN MAO (MARS PRO)
    Product Code
    KNN
    Product Problem
    Yes
    Report Source
    Distributor report
    Reporter Location
    IL, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Description of Event or Problem · 1

    THIS EVENT WAS RPEORTED TO CUSTOMER SERVICE VIA A PHONE CALL FROM LAURA, THE END USERS DAUGHTER ON 03/06/2006. PER REPORTER HER MOTHER USED THE COMMODE LAST NIGHT. THE DAUGHTER CLAIMS THE MOTHER WAS INJURED. THE MOTHER CLAIMS "THE BACK RIGHT LEG SHEARED IN HALF." THE DAUGHTER DESCRIBES THE LOCATION OF THE BREAK AS NEAR THE TOP OF THE LEG. THE DAUGHTER CLAIMS HER MOTHER RECEIVED QUITE A FEW INJURIES AS A RESULT OF THE FALL SHE TOOK WHEN THE LAG BROKE. WHEN ASKED IF HER MOTHER HAD BEEN TAKEN TO HER DOCTOR. THE DAUGHTER CLAIMS THEY WILL BE VISITING THE ER TODAY. THE DAUGHTER CLAIMS THE END USER HAS THE FOLLOWING INJURIES: RIGHT WRIST POSSIBLY BROKEN, RIGHT SIDE FACE AND HEAD BRUISED, RIBS ON HER RIGHT SIDE VERY BRUISED. LASTLY HER RIGHT ELBOW AND PALM OF HER RIGHT HAND HAVE CUTS AND ABRASIONC AFTER THE EVENT REPORTER CALLED AGAIN AND REPORTED THAT HER MOTHER SUFFERED A LARGE HEMOTOMA AND IS BEING OBSERVED OVER THE NEXT TWO WEEKS FOR BLEEDING. SUNRISE HAS REQUESTED THE UNIT BE RETURNED FOR EVALUATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 GUARDIAN COMMODE ALUMINUM SINGLE PACK KNN JAN MAO (MARS PRO) 30210-1 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 74 YR Hospitalization| O