FDA Adverse Event Malfunction Summary report: N

MOTORIZED 3-WHEELED VEHICLE FOR OUTSIDE TRANSPORT

MDR report key: 2186987 · Received August 2, 2011

Report

Report Number: 1525712-2011-00408
Event Type: Malfunction
Date Received: August 2, 2011
Report Date: August 2, 2011
Manufacturer: C.T.M. HOMECARE PRODUCT, INC
Product Code: INI
Report Source: Manufacturer report
Reporter Location: IA, US
Reporter Occupation: OTHER

Narratives

Additional Manufacturer Narrative · 1

THIS SCOOTER MODEL LEO-4S, (B)(4) IS AN INVACARE SALES DEMO. IT IS NOT OWNED BY THE DEALER OR THE CONSUMER. THE DEMO SCOOTER IS USED FOR SALES PURPOSES AND THE CONSUMER WAS TEST DRIVING THE DEVICE BEFORE PURCHASE. IT IS UNKNOWN IF THE CONSUMER HAS READ AND FULLY UNDERSTANDS THE LABELING FOR THIS DEVICE. THE CONSUMER'S WEIGHT IS 300 LBS AND THE LEO-4S HAS A WEIGHT LIMIT OF 350 LBS. THE USER MANUAL LEO SCOOTER PART NO. 1163141 ON PAGE 2 HAS A WEIGHT SPECIFICATION OF 350 LBS WITH A SPECIAL NOTE WHICH STATES: "NOTE: WEIGHT LIMITATION IS TOTAL WEIGHT (USER WEIGHT PLUS ANY ADDITIONAL ITEMS THAT THE USER MAY REQUIRE [BACK PACK, ETC.]). EXAMPLE:IF WEIGHT LIMITATION OF THE SCOOTER IS 350 LBS AND ADDITIONAL ITEMS EQUAL 25 LBS, SUBTRACT 25 LBS FROM 350 LBS THIS MEANS THE MAXIMUM WEIGHT LIMITATION OF THE USER IS 325 LBS." IT IS UNKNOWN IF THE CONSUMER WAS USING A BACK PACK, HAULING GROCERIES OR AFFECTING THE LOADING OF THE SCOOTER IN A MANNER THAT COULD CAUSE THE BACK OF THE VAN SEAT TO BREAK AT THE HINGE. (B)(4) HAS BEEN ISSUED FOR THIS SCOOTER TO BE RETURNED FOR EVALUATION.

Description of Event or Problem · 1

THE BACK ON THE VAN SEAT ALLEGEDLY BROKE AT THE HINGE, CAUSING THE CONSUMER TO FALL OFF THE SCOOTER. NO SERIOUS INJURY IS ALLEGED.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
1	MOTORIZED 3-WHEELED VEHICLE FOR OUTSIDE TRANSPORT	890.3800	INI	C.T.M. HOMECARE PRODUCT, INC	LEO-4S

Patients

Seq	Age	Sex	Outcome	Treatment
1