BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PRIDE

    MDR report key: 2033549 · Received March 30, 2011

    Report

    Report Number
    2530130-2011-00013
    Event Type
    Injury
    Date Received
    March 30, 2011
    Date of Event
    May 14, 2010
    Report Date
    March 30, 2011
    Manufacturer
    PRIDE MOBILITY PRODUCTS CORPORATION
    Product Code
    ITI
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    ATTORNEY

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE IS NOT AVAILABLE FOR EVALUATION AT THIS TIME. SHOULD THE DEVICE BECOME AVAILABLE FOR EVALUATION, A FOLLOW UP REPORT WILL BE SUBMITTED UPON COMPLETION OF INVESTIGATION.

    Description of Event or Problem · 1

    THE USER ALLEGES THAT HE SUSTAINED INJURIES AS A RESULT OF AN ACCIDENT CAUSED BY A MALFUNCTION IN THE WHEELCHAIR. THE USER REQUIRED HOSPITALIZATION FOR A HEMATOMA TO THE RIGHT ELBOW.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PRIDE POWERCHAIR ITI PRIDE MOBILITY PRODUCTS CORPORATION JET 2

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization