BEUDAMED
    FDA Adverse Event Death Summary report: N

    DIRVE MEDICAL

    MDR report key: 953599 · Received November 21, 2007

    Report

    Report Number
    2438477-2007-00005
    Event Type
    Death
    Date Received
    November 21, 2007
    Date of Event
    April 29, 2007
    Report Date
    October 25, 2007
    Manufacturer
    MEDICAL DEPOT, INC/ (D/B/A DRIVE MEDICAL DESIGN & MFG)
    Product Code
    ITJ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE PRODUCT MALFUNCTION OR DEFECT WAS REPORTED BY THE INITIAL REPORTER. OUR PRODUCT INSTRUCTION PROVIDES SAFETY PRECAUTIONS TO THE USERS, WHICH CLEARLY STATED THAT "DO NOT HAVE ANYONE PUSH YOU WHILE YOU ARE SEATED ON THE ROLLATOR. THIS IS A WALKING AID ONLY AND IS NOT TO BE USED AS A TRANSPORTATION DEVICE." IT WAS REPORTED THAT THE USER WAS SITTING ON THE ROLLATOR WHILE BEING PUSHED BY ANOTHER PERSON, AT THE TIME OF EVENT. WE HAVE CONTACTED THE INITIAL REPORTER SEVERAL TIMES REQUESTING ADDITIONAL INFO AND/OR INSPECTION ON THE DEVICE, BUT REC'D VERY LIMITED RESPONSE AT THE TIME OF FILING THIS REPORT. WE WILL FILE A FOLLOW-UP REPORT TO THE FDA IF ADDITIONAL INFO BECOMES AVAILABLE TO US.

    Description of Event or Problem · 1

    THE USER LIVED IN AN ASSISTED LIVING FACILITY AND WAS ASSISTED BY STAFF MEMBER TO THE DINING ROOM. THE USER WAS UNSTEADY, AND WAS SEATED ON ROLLATOR WHILE BEING PUSHED BY THE AIDE. AS A RESULT OF BEING PUSHED BY THE AIDE, THE ROLLATOR FLIPPED BACKWARDS CAUSING THE USER TO STRIKE HER HEAD ON A TILE FLOOR. SHE DID SEEK MEDICAL ATTENTION. SHE SUBSEQUENTLY DEVELOPED A SUBDURAL HEMATOMA, RESULTING IN DEATH, LATER THAT DAY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 DIRVE MEDICAL ROLLATOR ITJ MEDICAL DEPOT, INC/ (D/B/A DRIVE MEDICAL DESIGN & MFG) 10208PSBL-1 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 86 YR Death