BEUDAMED
    FDA Adverse Event Other Summary report: N

    INDEPENDENCE IBOT 4000 MOBILITY SYSTEM

    MDR report key: 1007973 · Received March 3, 2008

    Report

    Report Number
    3003508375-2008-00001
    Event Type
    Other
    Date Received
    March 3, 2008
    Date of Event
    September 3, 2006
    Report Date
    February 29, 2008
    Manufacturer
    INDEPENDENCE TECHNOLOGY, L.L.C.
    Product Code
    IMK
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THE USER REPORTED THE EVENT TO THE CO IN 2008, ALTHOUGH THE EVENT OCCURRED IN 2006. THERE IS NO INDICATION OF DEVICE MALFUNCTION, RATHER, STATEMENTS FROM THE USER SUGGEST THAT THE EVENT OCCURRED AS A RESULT OF THE USER NOT BEING FULLY COGNIZANT OF HIS SURROUNDINGS. THE DEVICE WAS NOT RETURNED, OR MADE AVAILABLE FOR EVAL. NO FURTHER ACTION WILL BE TAKEN BY THE CO.

    Description of Event or Problem · 1

    DURING AN UNRELATED CONVERSATION WITH THE CO SVC MGR IN 2008, A USER REPORTED AN EVENT THAT OCCURRED IN 2006. USER REPORTED THAT HE WAS BREWING BEER AND "RUSHING A BIT TO GET THINGS DONE". USER DID NOT NOTICE THAT A WHEEL WAS TANGLED IN A COOLING LINE FOR A 6 GALLOON TURKEY FRYER BEING USED TO BOIL THE BEER, AND WHEN MOVING THE DEVICE, THE JUST BOILED CONTENTS OF THE FRYER WAS SPILLED OVER HIM. USER STATED THAT HE WAS HOSPITALIZED FOR A PERIOD OF TIME, BUT DID NOT PROVIDE ANY FURTHER DETAILS, THE EXACT DATE OF THE EVENT IS NOT KNOWN, BUT HAS BEEN ENTERED AS TWO DAYS LATER, FOR REPORTING PURPOSES. THERE IS NO INDICATION OF ANY DEVICE MALFUNCTION ASSOCIATED WITH THIS EVENT, HOWEVER THE CO HAS ELECTED TO FILE A MEDICAL DEVICE REPORT AFTER BECOMING AWARE OF THE USER'S INJURY AND HOSPITALIZATION. THIS REPORT CORRESPONDS TO INDEPENDENCE TECHNOLOGY COMPLAINT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INDEPENDENCE IBOT 4000 MOBILITY SYSTEM STAIR CLIMBING WHEELCHAIR IMK INDEPENDENCE TECHNOLOGY, L.L.C. NA

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization