BEUDAMED
    FDA Adverse Event Death Summary report: N

    PRIDE MOBILITY PRODUCTS

    MDR report key: 2302022 · Received October 20, 2011

    Report

    Report Number
    2530130-2011-00046
    Event Type
    Death
    Date Received
    October 20, 2011
    Date of Event
    August 20, 2011
    Report Date
    November 22, 2011
    Manufacturer
    PRIDE MOBILITY PRODUCTS
    Product Code
    INI
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE NOT EVALUATED. WILL SUBMIT A FOLLOW-UP INVESTIGATION REPORT SHOULD THE DEVICE BECOME AVAILABLE FOR EVALUATION.

    Additional Manufacturer Narrative · 1

    INSPECTION OF THE DEVICE AND ACCIDENT SITE WAS CONDUCTED. PRODUCT WAS TEST DRIVEN AND PERFORMED AS DESIGNED. THE HILL WHERE THE ALLEGED INCIDENT OCCURRED WAS APPROXIMATELY 10° AND EXCEEDED THE SLOPE AS OUTLINED IN THE OWNER'S MANUAL. THE PRODUCT WOULD BE CAPABLE OF SUCCESSFULLY TRAVERSING THE SLOPE AS LONG AS THE CONSUMER REMAINED PARALLEL TO THE ROADWAY. IT IS UNKNOWN WHAT CREATED THE CIRCUMSTANCES SURROUNDING THE INCIDENT. ALL SAFETY MECHANISMS WITHIN THE PRODUCT APPEARED TO BE FUNCTIONING APPROPRIATELY. THE CIRCUMSTANCES SURROUNDING THE EVENT ARE UNKNOWN AND OTHER FACTORS MAY HAVE CONTRIBUTED TO THE EVENT.

    Description of Event or Problem · 1

    RECEIVED A CALL FROM INITIAL REPORTER WHO IS INVESTIGATING THE DEATH OF A WOMAN WHO WAS FOUND ON THE SIDE OF THE ROAD DECEASED WITH HER SCOOTER LAYING FLAT ON GROUND.

    Description of Event or Problem · 1

    RECEIVED A CALL FROM INITIAL REPORTER WHO IS INVESTIGATING THE DEATH OF A WOMAN WHO WAS FOUND ON THE SIDE OF THE ROAD DECEASED WITH HER SCOOTER LAYING FLAT ON GROUND.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PRIDE MOBILITY PRODUCTS MOTORIZED THREE-WHEELED VEHICLE INI PRIDE MOBILITY PRODUCTS SC4401

    Patients

    Seq Age Sex Outcome Treatment
    1 Death