MAUDE Adverse Event Report: C.T.M. TAIWAN MOTORIZED 3-WHEELED VEHICLE FOR OUTSIDE TRANSPORT; 890.3800

Model Number LEO-3S

Device Problem Break (1069)

Patient Problems Fall (1848); No Information (3190)

Event Date 09/18/2014

Event Type  No Answer Provided  

Event Description

Dealer stated that the seat on a leo-3s scooter broke at the side hinge, at the bolt, causing the end user to be flipped out of the scooter.User was taken by ambulance to the hospital.Dealer is not aware of the extent of the injuries.

• Brand Name: MOTORIZED 3-WHEELED VEHICLE FOR OUTSIDE TRANSPORT
• Type of Device: 890.3800
• Manufacturer (Section D): C.T.M. TAIWAN; no. 33-12, lin 1; chiu tou village; taoyuan hsien 327 ; TW 327
• MDR Report Key: 4129622
• MDR Text Key: 21807566
• Report Number: 1531186-2014-04554
• 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: Invalid Data
• Reporter Occupation: Medical Equipment Company Technician/Representative
• Type of Report: Initial
• Report Date: 09/30/2014,09/19/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: LEO-3S
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 09/30/2014
• Distributor Facility Aware Date: 09/19/2014
• Device Age: 17 MO
• Event Location: Other
• Date Report to Manufacturer: 09/30/2014
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 09/30/2014
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other