BEUDAMED
    FDA Adverse Event Summary report: N

    PC8 ( PERFECT COMBO)

    MDR report key: 785641 · Received June 13, 2006

    Report

    Report Number
    MW1041023
    Date Received
    June 13, 2006
    Date of Event
    May 6, 2006
    Report Date
    June 13, 2006
    Manufacturer
    TZOR, ACTIVE SYSTEMS LIMITED
    Product Code
    INI
    Report Source
    Voluntary report
    Reporter Location
    PA, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    REPORTER STATES THAT SHE IS A DIABETIC WITH A BROKEN FOOT WHO USED UP HER 401K IN ORDER TO PURCHASE THE PC8 (PERFECTOCOMBO) MOTOR SCOOTER AND SHE SAYS THAT THE ACTUAL PRODUCT LOOKS NOTHING LIKE WHAT THEY ADVERTISED IN THE PICTURE. SHE STATES THAT SHE PAID FOR THE SCOOTER WITH (4) U.S. POSTAL MONEY ORDERS (INCREMENTAL AMOUNTS, RATHER THAN ALLOW THE COMPANY TO ACCESS HER BANK ACCOUNT). PROBLEM #1/3 REPORTER STATES THAT THE PC8 SCOOTER WILL STOP ON A DIME. THEY USUALLY TRAVEL AT 2-3 MPH & THERE'S A PIN THAT CONTROLS THE POWER , & IF IT FALLS OUT, THE SCOOTER WILL STOP ABRUPTLY AND YOU'LL TUMBLE OUT THE SEAT. THE PIN IS UNCOVERED, AND THERE'S NO SEAT BELT. SCOOTER IS DANGEROUS! PROBLEM#2 THIS SCOOTER TRAVELS APPROX. 8MPH, MUCH FASTER THAN MOST, YOU'LL BE THROWN FROM YOUR SEAT & YOU'LL BREAK YOU NECK. WITH EXPERIENCE USING "CRASH DUMMIES" SHE FEELS CONFIDENT THAT THIS IS WHAT WILL HAPPEN. ADDITIONALLY, THERE'S NO"SHROUD" (COVER) SUCH THAT THE BATTERY & ALL WIRES ARE LEFT EXPOSED. LIVING IN A RAINFALL CITY AS SHE, ANY AMOUNT OF WATER CONTACT TO THESE ELECTRICAL COMPONENTS WOULD DEFINITELY CAUSE A SHORT-OUT. PROBLEM#3 THE STEERING CONTROLS ARE ALL EXPOSED & OPEN. SHE REALLY HAS CONCERNS THAT THE SCOOTERS MAY BE UTILIZED FOR SMUGGLING PURPOSES, ESPECIALLY GOLD @ $800/OUNCE, ONE COULD EASILY SMUGGLE 1/4 MILLION DOLLARS WORTH OF GOLD IN THIS MANNER. LASTLY, THE WHEELS ARE A CONCERN. SHE PAID AN EXTRA MONEY PER WHEEL FOR SCOOTER TIRES THAT WOULDN'T DEFLATE,THAT RAISED THE PRICE OF THE SCOOTER. THE TIRES WERE SHIPPED DEFLATED, AND WERE LUMPY & BUMPY AND WAVY APPEARING. JUST A HAZARD IN THEM SELVES AND A HASSLE FOR SOMEONE WHEELCHAIR BOUND TO INFLATE. THE REPORTER HAS BEEN FIGHTING TO GET HER MONEY BACK. THE SCOOTER WAS FINALLY PICKED UP BY THE COMPANY 2 WEEKS AGO. SHE WANTS TO GET HER MONEY BACK. SHIPPING CO PICKED UP THE SCOOTER, BUT THEY HAD WANTED FOR HER TO PAY FOR RETURNING. SHE HOPES TO BE GETTING A REFUND CHECK SOON. AND SAYS THAT THE PRODUCT IS ONE OF THE MOST DANGEROUS THINGS IN CALIFORNIA. IT NEEDS TO BE TAKEN OFF THE MARKET.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PC8 ( PERFECT COMBO) MOTOR SCOOTER INI TZOR, ACTIVE SYSTEMS LIMITED 6801 & 6802 *

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR