BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AMIGO

    MDR report key: 273634 · Received April 14, 2000

    Report

    Report Number
    MW1018662
    Event Type
    Injury
    Date Received
    April 14, 2000
    Date of Event
    February 1, 2000
    Report Date
    April 14, 2000
    Manufacturer
    AMIGO MOBILITY INT'L, INC.
    Product Code
    INI
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    NV, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    SCOOTER TIPPED OVER BACKWARDS GOING UP A LOW GRADE INCLINE. USER SUFFERED A SKULL LACERATION WITH BLEEDING ("ALL NIGHT"), AND WAS BADLY BRUISED ON THEIR SCALP. WAS SEEN ON THE SCENE BY PARAMEDICS BUT WAS NOT SEEN IN ER OR BY FAMILY PHYSICIAN. DID NOT REQUIRE SUTURES BUT DID TAKE HYDROCODONE FOR THE PAIN. RPTR RECENTLY PURCHASED THE SCOOTER. IT IS SMALL AND COMPACT AND RPTR PURCHASED IT BECAUSE IT WAS SOMETHING THAT THEY CAN HANDLE BY THEMSELVES. IT WILL TIP OVER BACKWARD ON A SLIGHT INCLINE. THERE ARE HANDICAP INCLINES WHERE RPTR LIVES. IF ONE DOES NOT GO FAST ENOUGH UP THESE INCLINES AND LEAN FORWARD, THIS UNIT WILL TIP. UNFORTUNATELY, RPTR DID NOT KNOW THIS AND IT ROLLED BACKWARDS AND RPTR TIPPED OVER BACKWARDS, HITTING HEAD EXTREMELY HARD ON THE BLACKTOP. IT IS WELL OVER 6 WEEKS NOW AND RPTR'S HEAD IS STILL SORE WHERE IT WAS CUT. RPTR FEELS THAT IF THEY WENT FOR A MRI THAT IT WOULD SHOW THAT SKULL HAS BEEN RECENTLY FRACTURED AND THEY CANNOT DO ANYTHING FOR A FRACTURED SKULL. MAYBE SOME LITTLE STABILIZER WHEELS ON EACH SIDE WOULD DO SOMETHING. RPTR FEELS THIS IS VERY SERIOUS AND SOMETHING NOT TO BE TAKEN LIGHTLY AND SUGGESTS ENGINEERS GET BUSY REDESIGNING THIS PARTICULAR UNIT ASAP.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 AMIGO MOTORIZED SCOOTER INI AMIGO MOBILITY INT'L, INC. FD NA

    Patients

    Seq Age Sex Outcome Treatment
    1 61 YR