BEUDAMED
    FDA Adverse Event Injury Summary report: N

    JAZZY SELECT

    MDR report key: 1202003 · Received October 6, 2008

    Report

    Report Number
    MW5008607
    Event Type
    Injury
    Date Received
    October 6, 2008
    Date of Event
    March 14, 2007
    Report Date
    October 6, 2008
    Product Code
    INI
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    MO, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    IN EARLY 2007, I CALLED NEAREST WHEELCHAIR LOCATION. I WAS CONTACTED BY CO. I WAS QUESTIONED, SIGNED A RELEASE. MY DR DO RX W/C ELECT JAZZY SELECT. THE DELIVERY OF THE ELECT W/C WAS 2 MOS LATE. THE 2 MEN CAME AT MIDNIGHT MARCH 14-15, 07 FOR 4 HOURS TRIED W/C AND SIGNED PAPERS. THE WHEELCHAIR IS A LEMON. I FOUND MADE IN ANOTHER COUNTRY. STICKERS WITH DIFFERENT MODEL NUMBER, USA LABELS WERE PLACED OVER THEM- THE BATTERY WON'T STAY CHARGED, THE JAZZY STICK WON'T STEER RIGHT. I ALMOST GOT MASHED IN IT GOING INTO AN ELEVATOR. ITS WHEEL ON (RIGHT) SIDE STICKS ON SHROUD., CO, FAILED TO WARRANTEE PRODUCT PROPERLY. PROMISED WITH WITNESS 3 WAY PHONE JAN 08 TO REPLACE WITH JAZZY SELECT. ON SEVERAL OCCASIONS, I CALLED TO REPORT MALFUNCTIONS DURING BUSINESS HOURS WITH BEING HUNG-UP ON. MEN SHOWING UP AFTER NORMAL BUSINESS HOURS NEVER ON TIME, HAD TO HIRE ATTY TO HELP ME AT ONE POINT. HE CAME TO MY HOUSE TO TELL THE 2 MEN TO FIX MY WHEELCHAIR RIGHT. THEY DIDN'T. MY BACK L-5 DECREASED SHOWS OSTEOARTHRITIS WITH HERNIATED BULGED DISKS. I'M A HEART PT WITH COPD AND ADULT, ASTHMA, EDEMA, SWELLING OF LEGS WITH NEUROLOGICAL PROBLEMS 100 %. DISABLE FROM CAR ACCIDENT JULY 12 AT 12:30 AM. IN 1990, NEED WHEELCHAIR TO GET AROUND LIMITED MOBILITY. PRIDE MOBILITY HAS NOT PROPERLY COOPERATED WITH ME CURRENTLY. WON'T TAKE THIS DEFECTIVE ELECTRIC JAZZY SELECT PRIDE MOBILITY WHEELCHAIR AND BRING ME A NEW ONE AS PROMISED JAN 2008. NO PRIDE IN THIS RIDE. PERSONALLY, I THINK IT IS PHYSICALLY, MENTALLY AND EMOTIONALLY ABUSIVE TO PUT A LIMITED MOBILITY BROKEN PERSON, HUMAN BODY INTO A BROKEN WHEELCHAIR. PRIDE MOBILITY JAZZY SELECT HOLDS DOES NOT WORK PROPERLY. BEEN MASHED IN ELEVATOR HOME. STRANDED WHERE IT QUIT RUNNING AWAY FROM HOME. DATES OF USE: 2007 THRU CURRENT WITH SEVERAL MALFUNCTIONS. DIAGNOSIS OR REASON FOR USE: HTN, HEART PT, COPY BAD BACK, COPD, OSTEO ARTHRITIS ALL JOINTS, HANDICAP LIMITED MOBILITY. EVENT ABATED AFTER USE STOPPED OR DOSE REDUCED: NO. EVENT REAPPEARED AFTER REINTRODUCTION: YES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 JAZZY SELECT ELECTRIC WHEELCHAIR INI J8335406096C30, J8303007270420

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| L| O| R