BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PACER GAIT TRAINER

    MDR report key: 1062743 · Received June 17, 2008

    Report

    Report Number
    1319061-2008-00002
    Event Type
    Injury
    Date Received
    June 17, 2008
    Date of Event
    May 19, 2008
    Report Date
    May 26, 2008
    Manufacturer
    RIFTON EQUIPMENT
    Product Code
    INN
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THE CONSUMER MAY NOT HAVE READ THE WARNINGS IN THE PRODUCT MANUAL, WHICH CLEARLY STATE THAT: "ADULT SUPERVISION IS REQUIRED AT ALL TIMES." "USE ONLY ON LEVEL GROUND OR INDOORS. DO NOT USE NEAR STEPS, SLOPED DRIVEWAYS, ROADS, ALLEYS, OR SWIMMING POOLS." "ALL MOBILITY EQUIPMENT CAN BECOME UNSTABLE WHEN USED INAPPROPRIATELY." IT WARNS ABOUT USE ON: UNEVEN GROUND, INAPPROPRIATE PROMPT PLACEMENT, ESPECIALLY IN EXTREME FORWARD OR REVERSE POSITIONS. RAMPS/SLOPES/HILLS. SUDDEN STOPS FROM HITTING A CURB, CRACK, OR DEBRIS.

    Description of Event or Problem · 1

    SOURCE REPORTED THAT HER DAUGHTER WAS IN THE YARD WITH HER GRANDMOTHER WHO WAS NOT WATCHING WHEN THE CHILD FELL, HAD A CONCUSSION AND WAS UNCONSCIOUS IN THE HOSPITAL FOR SEVERAL DAYS AND IS NOW HOME WITH NO PERMANENT DAMAGE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PACER GAIT TRAINER GAIT TRAINER INN RIFTON EQUIPMENT K503 K50320071115AA

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Hospitalization