BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TIGER

    MDR report key: 311162 · Received January 2, 2001

    Report

    Report Number
    1525712-2000-00097
    Event Type
    Injury
    Date Received
    January 2, 2001
    Date of Event
    September 1, 2000
    Report Date
    December 7, 2000
    Manufacturer
    INVACARE CORPORATION
    Product Code
    ITI
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UT, US
    Reporter Occupation
    PATIENT FAMILY MEMBER OR FRIEND

    Narratives

    Description of Event or Problem · 1

    MANUFACTURER RECEIVED A REPORT ALLEGING THAT WHILE THE USER WAS LEARNING HOW TO DRIVE THE CHAIR, USER ACCIDENTALLY CHANGED FROM DRIVE 1 TO DRIVE 2. THIS CAUSED THE CHAIR TO TAKE OFF AND HIT A BY STANDER IN THE STOMACH. AS A RESULT, THE BY STANDER RECEIVED AN INTESTINAL INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    37 TIGER POWERED WHEELCHAIR ITI INVACARE CORPORATION TIGER (POWER) NA

    Patients

    Seq Age Sex Outcome Treatment
    1 3 YR Required Intervention