BEUDAMED
    FDA Adverse Event Summary report: N

    PRIDE MOBILITY PRODUCTS

    MDR report key: 2670603 · Received July 26, 2012

    Report

    Report Number
    2530130-2012-00049
    Date Received
    July 26, 2012
    Date of Event
    July 10, 2012
    Report Date
    March 8, 2013
    Manufacturer
    PRIDE MOBILITY PRODUCTS
    Product Code
    INI
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    ME, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THIS DEVICE WAS THE SUBJECT OF A RECALL. ALTHOUGH THE PROVIDER WAS CONTACTED ON SEVERAL DIFFERENT OCCASIONS, THE EXAMINATION OF THE HARNESS SHOWS THAT THE SUBJECT DEVICE WAS NOT CORRECTED VIA THE RECALL.

    Additional Manufacturer Narrative · 1

    THE DEVICE IS NOT AVAILABLE FOR EVALUATION AT THIS TIME. A FOLLOW-UP REPORT WILL BE ISSUED IF MORE INFORMATION OR THE DEVICE BECOME AVAILABLE.

    Description of Event or Problem · 1

    PROVIDER ALLEGES, THE CUSTOMER CALLED ALLEGING HIS SCOOTER WAS ON A DECK UNDER AN AWNING WHEN IT BURST INTO FLAMES. THE UNIT WAS NOT PLUGGED IN AT THE TIME.

    Description of Event or Problem · 1

    PROVIDER ALLEGES THE CUSTOMER CALLED ALLEGING HIS SCOOTER WAS ON A DECK UNDER AN AWNING WHEN IT BURST INTO FLAMES. THE UNIT WAS NOT PLUGGED IN AT THE TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PRIDE MOBILITY PRODUCTS MOTORIZED THREE WHEELED VEHICLE INI PRIDE MOBILITY PRODUCTS VICTORY 3 WHEEL

    Patients

    Seq Age Sex Outcome Treatment
    1 Life Threatening