BEUDAMED
    FDA Adverse Event Injury Summary report: N

    POWERED WHEELCHAIR

    MDR report key: 1821159 · Received August 26, 2010

    Report

    Report Number
    1525712-2010-00121
    Event Type
    Injury
    Date Received
    August 26, 2010
    Date of Event
    February 22, 2010
    Report Date
    August 25, 2010
    Manufacturer
    INVACARE
    Product Code
    ITI
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    A USER WAS LOANED AN INVACARE CHAIR BY THEIR SERVICE PROVIDER WHILE THEIR ORIGINAL CHAIR WAS IN NEED OF SERVICE. WHILE USING THIS LOANER CHAIR, THE CONSUMER ALLEGEDLY FELL OUT AND BROKE HER ARM. DETAILS OF EVENT WERE NOT PROVIDED BY THE USER'S FAMILY MEMBER. LOGS OF THE SERVICE TRANSACTIONS WERE OBTAINED AND A MODEL NUMBER OF THE CHAIR LOANED WAS VERIFIED ON (B)(6) 2010. THE USER WAS IN NEED OF A SMALLER CHAIR THAN THE LOANER THEY WERE PROVIDED. THIS LARGER CHAIR APPEARED TO BE INAPPROPRIATE FOR THIS USER. THE USER'S ORIGINAL CHAIR HAS SINCE BEEN REPAIRED AND IS BACK IN SERVICE. NO MALFUNCTION IS APPARENT AND LOANER CHAIR REMAINS IN USE AT THE SERVICE FACILITY. MDR FILED BASED ON ALLEGED UNCONFIRMED INJURY.

    Description of Event or Problem · 1

    THE CONSUMER WAS MOVING AROUND THE ROOM AND ALLEGEDLY FELL OUT OF THE CHAIR AND HIT THE FLOOR, RESULTING IN A BROKEN LEFT SHOULDER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 POWERED WHEELCHAIR 890.3860 ITI INVACARE M51

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention