BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INVACARE SCOOTERS

    MDR report key: 1080421 · Received July 16, 2008

    Report

    Report Number
    1525712-2008-00065
    Event Type
    Injury
    Date Received
    July 16, 2008
    Date of Event
    April 10, 2008
    Report Date
    July 14, 2008
    Manufacturer
    DISTRIBUTED PRODUCT
    Product Code
    INI
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    NO INFORMATION

    Narratives

    Additional Manufacturer Narrative · 1

    MFR CONTACTED DEALER. DEALER WAS UNAWARE OF ANY ISSUES WITH THE USER'S SCOOTER. CONSUMER REPORTS WHILE TRANSGRESSING NEAR A GULLY, THE SCOOTER JUST FLIPPED OVER ON ITS SIDE, THROWING HER IN THE GULLY. CONVERSATION WITH THE CONSUMER SUGGESTS USER WAS TRANSGRESSING THIS AREA WITH THE SPEED SETTING HIGH. NO CONFIRMATION OF INJURY OR TREATMENT HAS BEEN CONFIRMED. NO MALFUNCTION ALLEGED. AREA TRANSGRESSED IS UNK. CURRENT USER GUIDE COVERS THIS AREA. MDR FILED BASED ON INJURY.

    Description of Event or Problem · 1

    THE CONSUMER WAS RIDING IN HER YARD, WHEN THE SCOOTER ALLEGEDLY FLIPPED OVER ON HER, RESULTING IN A BROKEN SHOULDER IN 4 PLACES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INVACARE SCOOTERS 890.3800 INI DISTRIBUTED PRODUCT L-3 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention