BEUDAMED
    FDA Adverse Event Injury Summary report: N

    QUICKIE

    MDR report key: 1623549 · Received March 1, 2010

    Report

    Report Number
    2937137-2010-00001
    Event Type
    Injury
    Date Received
    March 1, 2010
    Date of Event
    June 12, 2007
    Report Date
    February 25, 2010
    Manufacturer
    SUNRISE MEDICAL, INC.
    Product Code
    ITI
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CT, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT WAS NOT RETURNED TO MANUFACTURER FOR EVALUATION, AND IT IS UNK IF OR WHEN MANUFACTURER MAY HAVE THE OPPORTUNITY TO EVALUATE. IT DOES NOT APPEAR THAT THE PRODUCT HAD MALFUNCTIONED BUT MAY IN HOW THE USER UNFOLDED THE CHAIR. MANUFACTURE DOES NOT HAVE ALL DETAILS OF INJURY OR EVENT AT THIS TIME.

    Description of Event or Problem · 1

    IT HAS BEEN REPORTED THAT USER WAS OPENING WHEELCHAIR, THE X-HINGE MECHANISM CLOSED ON HIS RIGHT INDEX FINGER, CAUSING INJURY WHICH RESULTED IN PARTIAL AMPUTATION OF HIS RIGHT INDEX FINGER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 QUICKIE WHEELCHAIR, MECHANICAL ITI SUNRISE MEDICAL, INC. QUIICKIE 2 EIQ2

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Disability