BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ROLLATOR

    MDR report key: 3127084 · Received July 5, 2006

    Report

    Report Number
    2438477-2006-00002
    Event Type
    Injury
    Date Received
    July 5, 2006
    Date of Event
    May 31, 2006
    Report Date
    May 27, 2006
    Manufacturer
    MEDICAL DEPOT, INC (D/B/A DRIVE MEDICAL DESIGN & MFG)
    Product Code
    NXE
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    PT'S DAUGHTER CALLED IN MARCH TO SAY HINGE ON ROLLATOR WAS BROKEN. SHE WAS TOLD PART WAS ON BACKORDER. IT WAS UNDERSTOOD THAT IF PART WAS NOT WORKING NOT TO USE IT. ROLLATOR CONTINUED TO BE USED WHILE WAITING FOR REPLACEMENT PART AND PT THEN FELL WITH ROLLATOR. WE DO NOT BELIEVE IT WAS A MALFUNCTION, HOWEVER, SINCE THE PT WAS AWARE OF THE FACT THAT PRODUCT NEEDED A PART, WE BELIEVE THAT THIS INCIDENT WAS A USER ERROR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ROLLATOR NONE NXE MEDICAL DEPOT, INC (D/B/A DRIVE MEDICAL DESIGN & MFG) UNAVAILABLE UNAVAILABLE

    Patients

    Seq Age Sex Outcome Treatment
    1 91 YR Hospitalization| R