BEUDAMED
    FDA Adverse Event Death Summary report: N

    DRIVE MEDICAL

    MDR report key: 1333775 · Received February 19, 2009

    Report

    Report Number
    2438477-2009-00002
    Event Type
    Death
    Date Received
    February 19, 2009
    Date of Event
    July 23, 2007
    Report Date
    February 13, 2009
    Manufacturer
    NA
    Product Code
    ITJ
    Adverse Event
    Yes
    Report Source
    Distributor report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    (B) (4) HAS RECEIVED A COURT LETTER FROM THE SECRETARY OF STATE OF (B) (6) ON 1/15/09. IT IS ALLEGED THAT ON THE DAY OF EVENT, THE PT WAS AT AN ASSISTED LIVING FACILITY WHERE SHE WAS BEING TRANSPORTED BY A CNA (CERTIFIED NURSE'S ASSISTANT) WITH A ROLLATOR. THE CNA HAD THE PT SIT ON THE SEAT OF THE ROLLATOR DURING THE TRANSPORTATION. WHEN THE ROLLATOR WAS BEING PUSHED OVER SOME FLOOR STRIPS, THE ROLLATOR ALLEGEDLY TIPPED OVER AND COLLAPSED CAUSING THE PT TO FALL TO THE GROUND AND HIT HER HEAD. THE PT ALLEGEDLY SUSTAINED A MASSIVE SUBDURAL HEMATOMA AS A RESULT, AND DIED THE NEXT DAY. THIS MDR REPORT IS BASED ON THE COURT LETTER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 DRIVE MEDICAL ROLLATOR ITJ NA GO-LITE NA

    Patients

    Seq Age Sex Outcome Treatment
    1 Death