BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DALTON

    MDR report key: 1781744 · Received July 26, 2010

    Report

    Report Number
    MW5016879
    Event Type
    Injury
    Date Received
    July 26, 2010
    Date of Event
    July 14, 2010
    Report Date
    July 26, 2010
    Manufacturer
    DALTON MEDICAL CORP
    Product Code
    ITJ
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    ON DALTON BLUE HEAVY DUTY ROLLATOR ITEM# AR-46400BL PURCHASED ON (B)(6) 2010, PT CAME INTO FACILITY TO PURCHASE ABOVE MENTIONED ITEM AND ON (B)(6) 2010, PT STATES THAT HE LOCKED WHEELS IN PLACE, THEN PROCEEDED TO SIT ON SEAT OF PRODUCT WHEN THE BRAKES ON PRODUCT POPPED LOOSE CAUSING THE ROLLATOR TO FALL BACKWARDS DOWN THE STAIRS. THE PT CONTINUED TO FALL DOWN STAIRS AND LANDED ON CONCRETE FLOOR. DATES OF USE: (B)(6) 2010 - (B)(6) 2010. DIAGNOSIS OR REASON FOR USE: 724.1; 728.87. EVENT ABATED AFTER USE STOPPED OR DOSE REDUCED: NO. EVENT REAPPEARED AFTER REINTRODUCTION: NO.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 DALTON HEAVY DUTY ROLLATOR ITJ DALTON MEDICAL CORP AR-46400-BL

    Patients

    Seq Age Sex Outcome Treatment
    1 46 YR Hospitalization| O