BEUDAMED
    FDA Adverse Event Death Summary report: N

    ROSCOE E-SERIES ROLLATOR

    MDR report key: 6364279 · Received February 28, 2017

    Report

    Report Number
    3012316249-2017-00019
    Event Type
    Death
    Date Received
    February 28, 2017
    Date of Event
    June 20, 2016
    Report Date
    July 1, 2019
    Manufacturer
    MAXHEALTH CORP.
    Product Code
    ITJ
    Adverse Event
    Yes
    Report Source
    Distributor report
    Reporter Location
    US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 0

    THE CONSUMER FELL FROM THE ROLLATOR ONTO THE CONCRETE SIDEWALK, AND SUSTAINED SEVERE INJURIES TO HER HEAD AND TO HER BRAIN. THE CONSUMER WAS OF ADVANCED AGE, AND WAS NOT FEELING WELL AT THE TIME, SO SHE WAS SITTING ON THE ROLLATOR AS HER DAUGHTER PUSHED IT, IN ORDER TO ENTER THE BUILDING FROM THE PARKING LOT. IT WAS NECESSARY TO PUSH THE CONSUMER UP A CONCRETE WHEELCHAIR RAMP LOCATED IN THE PARKING LOT TO THE SIDEWALK. AT THE TOP OF THE RAMP, AND AT THE POINT WHERE THE RAMP MET THE CONCRETE SIDEWALK, THE ELEVATION OF THE RAMP WAS NOT LEVEL WITH THE ELEVATION OF THE SIDEWALK - THIS POINT OF TRANSITION HAD BEEN CONSTRUCTED AND/OR MAINTAINED SUCH THAT THERE WAS AN ABRUPT ELEVATION CHANGE AND HAZARD WHERE THE RAMP MET THE SIDEWALK. AS THE CONSUMER WAS PUSHED UP THE RAMP, AND WHEN THE ROLLATOR REACHED THE TRANSITION POINT WHERE THE RAMP MET THE SIDEWALK, THE WHEELS OF THE ROLLATOR CAME INTO CONTACT WITH THE HAZARDOUS ELEVATION CHANGE, CAUSING THE ROLLATOR TO SUDDENLY AND UNEXPECTEDLY STOP AND PITCH OVER. THE CONSUMER FELL FROM THE ROLLATOR ONTO THE CONCRETE SIDEWALK AND SUSTAINED INJURIES TO HER HEAD AND TO HER BRAIN. THIS EVENT WAS CONSIDERED MISUSE OF THE ROLLATOR, AS THE DEVICE'S HANG TAG (USER MANUAL) STATES, UNDER SAFETY PRECAUTIONS, "DO NOT USE YOUR ROLLATOR AS A WHEELCHAIR. DO NOT USE ON ROUGH OR UNEVEN SURFACES. DOING SO MAY CAUSE IT TO TIP-OVER, RESULTING INJURY. NEVER USE STAIRS OR ESCALATORS WHILE USING THE ROLLATOR. DO NOT USE ON INCLINES OVER 80%."

    Description of Event or Problem · 0

    UPDATE TO PATIENT OUTCOME: COMPASS HEALTH BRANDS WAS MADE AWARE OF DEATH ON (B)(6) 2017, VIA ATTORNEY, BUT QUALITY DEPARTMENT/REGULATORY THAT FILES THE REPORTS WITH FDA WAS ONLY MADE AWARE OF "SERIOUS INJURIES" UNTIL 07/01/2019. CUSTOMER SERVICE ERROR IN DOCUMENTING COMPLAINT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    148842 ROSCOE E-SERIES ROLLATOR ROLLATOR ITJ MAXHEALTH CORP. 30166 N/A

    Patients

    Seq Age Sex Outcome Treatment
    1 Death| O