BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DRIVE

    MDR report key: 13656510 · Received March 2, 2022

    Report

    Report Number
    2438477-2022-00009
    Event Type
    Injury
    Date Received
    March 2, 2022
    Date of Event
    January 25, 2022
    Report Date
    March 7, 2022
    Manufacturer
    ZHONGSHAN A&J MEDICAL EQUIPMENT
    Product Code
    ITJ
    UDI-DI
    00822383288819
    Adverse Event
    Yes
    Report Source
    Distributor report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Description of Event or Problem · 0

    DRIVE DEVILBISS HEALTHCARE WAS NOTIFIED OF AN INCIDENT INVOLVING A ROLLATOR ON JANUARY 25TH. THE USER WAS USING THE ROLLATOR GOING DOWN THE STEPS. THE BRAKES WERE PRESSED BUT DID NOT FUNCTION CAUSING THE END-USER TO FALL. THE USER STATES THAT SHE WAS HOLDING ONTO THE ROLLATOR ON THE FIRST STEP WHILE GOING TO THE NEXT STEP WITH THE BRAKES ENGAGED BUT THE ROLLATOR MOVED, AND SHE FELL TO THE NEXT STEP. HER PHYSICAL THERAPIST TRIED TO BREAK HER FALL, BUT THE HANDLEBAR POKED HER IN THE SIDE, NEXT TO HER LEFT BREAST. HE THEN HELPED HER GET INTO THE HOUSE AND NO MEDICAL ATTENTION WAS REQUIRED. THE END USER SOUGHT MEDICAL ATTENTION ON JANUARY 28TH, THROUGH X-RAY IT WAS DETERMINED THAT SHE SUFFERED TWO BROKEN RIBS . NO ADDITIONAL INFORMATION IS AVAILABLE CURRENTLY. THE DEVICE IS INTENDED TO BE USED ON EVEN SURFACES NOT TRAVERSING STEPS. DRIVE IS CURRENTLY INVESTIGATING THE INCIDENT, INCLUDING ATTEMPTING TO RETRIEVE THE PRODUCT TO INSPECT IT.

    Description of Event or Problem · 0

    ON (B)(6) 2002, DRIVE DEVILBISS HEALTHCARE WAS NOTIFIED OF AN INCIDENT INVOLVING A ROLLATOR. THE END USER REPORTED THAT SHE WAS USING THE ROLLATOR GOING DOWN STEPS, AND THAT SHE WAS HOLDING ONTO THE ROLLATOR ON THE FIRST STEP WHILE GOING TO THE NEXT STEP WITH THE BRAKES ENGAGED, BUT THE ROLLATOR MOVED, AND SHE FELL TO THE NEXT STEP, CAUSING THE HANDLEBAR TO POKE HER IN THE SIDE. THE DEVICE IS INTENDED TO BE USED ON EVEN SURFACES, NOT STEPS, WHICH IS NOTED IN THE ROLLATOR'S HANGTAG ("USE ONLY ON EVEN AND SOLID SURFACES.") AFTER THE ACCIDENT, THE END USER'S PHYSICAL THERAPIST HELPED HER TO GET INSIDE HER HOUSE, AND SHE DID NOT SEEK MEDICAL ATTENTION. HOWEVER, SHE SOUGHT MEDICAL ATTENTION ON (B)(6), WHEN AN X-RAY DETERMINED THAT SHE HAD TWO BROKEN RIBS. DRIVE IS CURRENTLY INVESTIGATING THE INCIDENT, INCLUDING ATTEMPTING TO RETRIEVE THE PRODUCT TO INSPECT IT. WE WILL UPDATE THIS REPORT WITH ANY NEW INFORMATION THAT BECOMES AVAILABLE. .

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1533930 DRIVE OLLATOR ITJ ZHONGSHAN A&J MEDICAL EQUIPMENT RTL10266 00822383288819

    Patients

    Seq Age Sex Outcome Treatment
    1 73 YR Female Required Intervention