MAUDE Adverse Event Report: UNKNOWN LYNX L-3X COMPACT SCOOTER - BLUE 9153645573; VEHICLE, MOTORIZED 3-WHEELED

Model Number L-3B

Device Problems Break (1069); Unintended Collision (1429); Environmental Compatibility Problem (2929)

Patient Problems Fall (1848); Hip Fracture (2349)

Event Type  Injury  

Manufacturer Narrative

Should additional information become available a supplemental record will be filed.User¿s manual review 1143205 rev.G (page 7) warning - do not operate on roads, streets or highways.(page 9) always wear your seat positioning strap.Inasmuch as the seat positioning strap is an option on this scooter (you may order with or without the seat positioning strap), invacare strongly recommends ordering the seat positioning strap as an additional safeguard for the scooter user.The seat positioning strap is a positioning belt only.It is not designed for use as a safety device withstanding high stress loads such as auto or aircraft safety belts.If signs of wear appear, belt must be replaced immediately.(page 10) do not operate the powered scooter until you have checked that the surroundings are clear and that the area is safe for travel.(page 11) warning - do not attempt to drive over curbs or obstacles.Doing so may cause your powered scooter to turn over and cause bodily harm and/or damage to the scooter.

Event Description

Reporter alleges previous to getting the l-4b she had a l-3 scooter and she was driving down the street the road was torn up and not even with her driveway, the city was doing repairs to add sewage and end user asked the city worker when they were going to even the driveway with her road and the incident occurred 3 years ago and to this day the city has not repaired her driveway or road correctly, they are still uneven, she was going up her driveway and the scooter flipped up and she fell out of scooter and broke her hip and hospitalized for 2 months.The end user daughter replaced 3 wheel scooter with the 4 wheel scooter for more stability.Reporter states she is no longer using the 3 wheel scooter; it is not useable.

• Brand Name: LYNX L-3X COMPACT SCOOTER - BLUE 9153645573
• Type of Device: VEHICLE, MOTORIZED 3-WHEELED
• Manufacturer (Section D): UNKNOWN; OH
• Manufacturer (Section G): UNKNOWN; OH
• Manufacturer Contact: kevin guyton ; one invacare way; elyria, OH 44035 ; 8003336900
• MDR Report Key: 5433394
• MDR Text Key: 38088769
• Report Number: 1525712-2016-00480
• Device Sequence Number: 1
• Product Code: INI
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer
• Reporter Occupation: Patient
• Type of Report: Initial
• Report Date: 01/26/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/12/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: L-3B
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 01/26/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization