BEUDAMED
    FDA Adverse Event Summary report: N

    MOTORIZED 3-WHEELED VEHICLE FOR OUTSIDE TRANSPORT

    MDR report key: 2844146 · Received November 25, 2012

    Report

    Report Number
    1531186-2012-01477
    Date Received
    November 25, 2012
    Report Date
    November 25, 2012
    Manufacturer
    C.T.M. HOMECARE PRODUCT, INC
    Product Code
    INI
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    INVACARE CONSUMER AFFAIRS TALKED TO THE DEALER WHO STATED THAT THEY RECEIVED TWO DIFFERENT VERSIONS OF THE STORY FROM THE DAUGHTER AND THE CONSUMER. VERSION 1 (CONSUMER): THE CONSUMER LIVES IN AN APARTMENT COMPLEX. THE CONSUMER WAS EXITING HER BUILDING. SHE DROVE THROUGH SLIDING DOORS. THEY SLIDE BACK AND FORTH (GLASS DOORS). THE PATIENT STATED THAT THE DOOR DID NOT OPEN ALL THE WAY. THE SCOOTER ALLEGEDLY WAS CAUGHT AND THE DOOR PUSHED HER AGAINST THE WALL CAUSING THE SCOOTER TO FLIP AND LAND ON TOP OF HER. VERSION 2 (DAUGHTER OF CONSUMER): THE CONSUMER WAS EXITING THE BUILDING. GLASS DOORS ARE SLIDING INTO THE INTERIOR OF THE BUILDING. THE SCOOTER ALLEGEDLY TOOK OFF ON ITS OWN THROUGH THE DOORS CAUSING THE CONSUMER TO DRIVE DOWN THE STEPS. THE UNIT THEN FLIPPED ON TOP OF HER. THE DOORS OPEN AND THEN THERE IS AN AREA OF 3-4 FEET OF FLAT SURFACE AND THEN THERE ARE STEPS. THERE IS A HANDICAP RAMP TO THE LEFT OF THE DOORS. THE DEALER STATED THAT THEIR TECHNICIAN WENT OUT TO LOOK AT THE SCOOTER. THE ONLY THING IT NEEDS IS VELCRO THAT HOLDS THE SHROUD IN PLACE. THE DEALER IS REPLACING THIS. THE TECHNICIAN DID NOT FIND ANYTHING WRONG WITH THE UNIT. THE UNIT IS FUNCTIONING PROPERLY. WHEN ASKED ABOUT INJURIES, THE DEALER STATED THAT THE CONSUMER ALLEGEDLY SUSTAINED CRUSHED SHOULDERS, ELBOW, KNUCKLES, AND AN INJURED FOOT THAT SHE CANNOT PUT PRESSURE ON. THE CONSUMER HAS BEEN RELEASED FROM THE HOSPITAL. THE CONSUMER STILL NEEDS TO GO TO THERAPY AND THE DOCTOR TO SEE WHAT THEY ARE GOING TO DO WITH HER SHOULDER. THE CONSUMER STILL HAS THE UNIT. CONSUMER AFFAIRS ADVISED THE DEALER THAT INVACARE WOULD LIKE TO BRING THE UNIT BACK FOR AN INVESTIGATION.

    Description of Event or Problem · 1

    (B)(6) STATED THAT THE L-3XB SCOOTER ALLEGEDLY LUNGED FORWARD CAUSING THE USER TO FALL DOWN THE STAIRS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MOTORIZED 3-WHEELED VEHICLE FOR OUTSIDE TRANSPORT 890.3800 INI C.T.M. HOMECARE PRODUCT, INC L-3XB

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR Hospitalization| O