BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PRIDE MOBILITY PRODUCTS

    MDR report key: 1903415 · Received November 12, 2010

    Report

    Report Number
    2530130-2010-00063
    Event Type
    Injury
    Date Received
    November 12, 2010
    Date of Event
    May 8, 2010
    Report Date
    February 22, 2012
    Manufacturer
    PRIDE MOBILITY PRODUCTS
    Product Code
    ITI
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    ATTORNEY

    Narratives

    Additional Manufacturer Narrative · 1

    TTRANSFERS SHOULD BE ATTEMPTED WITH THE CONTROLLER OFF. WITH THE CONTROLLER OFF, THE DEVICE SHOWED NO EVIDENCE OF UNINTENDED MOVEMENT. PLEASE REFER TO ATTACHED RETURNED PRODUCT EVALUATION.

    Additional Manufacturer Narrative · 1

    METHOD: THE DEVICE IS NOT AVAILABLE FOR REVIEW AT THIS TIME, AND THE DEVICE SERIAL NUMBER HAS NOT BEEN VERIFIED. CONCLUSIONS: A FOLLOW UP REPORT WILL BE SUBMITTED IF THE PRODUCT SHOULD BECOME AVAILABLE FOR REVIEW.

    Description of Event or Problem · 1

    CUSTOMER WAS TRANSFERRING FROM BED TO THE UNIT WHEN HE INADVERTANTLY TURNED THE UNIT ON WHILE GRASPING THE JOYSTICK RESULTING IN A FALL. THE CUSTOMER SUSTAINED FRACTURED RIBS, SKIN LACERATIONS AND BRUISES.

    Description of Event or Problem · 1

    THE CUSTOMER WAS TRANSFERRING FROM THE BED TO THE POWERCHAIR WHEN HE INADVERTENTLY TURNED THE UNIT ON WHILE GRASPING THE JOYSTICK RESULTING IN A FALL. THE CUSTOMER SUSTAINED FRACTURED RIBS, SKIN LACERATIONS AND BRUISES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PRIDE MOBILITY PRODUCTS POWERED WHEELCHAIR ITI PRIDE MOBILITY PRODUCTS JET 3 ULTRA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Hospitalization| L