MAUDE Adverse Event Report: C.T.M. TAIWAN SCOOTER MIDSIZE 3 WHEEL SILVER 9153652403; VEHICLE, MOTORIZED 3-WHEELED

Model Number LEO-3S

Device Problems Bent (1059); Device Damaged Prior to Use (2284)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Type  malfunction  

Event Description

It has been reported by a provider that the transaxle is bent on a leo -3s scooter out of the box.

• Brand Name: SCOOTER MIDSIZE 3 WHEEL SILVER 9153652403
• Type of Device: VEHICLE, MOTORIZED 3-WHEELED
• Manufacturer (Section D): C.T.M. TAIWAN; no. 33-12, lin 1; chiu tou village; taoyuan hsien 327 ; TW 327
• MDR Report Key: 4449733
• MDR Text Key: 5427564
• Report Number: 1531186-2015-00549
• Device Sequence Number: 1
• Product Code: INI
• Combination Product (y/n): N
• Reporter Country Code: CA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Distributor
• Source Type: Invalid Data
• Reporter Occupation: Medical Equipment Company Technician/Representative
• Type of Report: Initial
• Report Date: 01/23/2015,01/16/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/26/2015
• Is this an Adverse Event Report?: No
• 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: 01/23/2015
• Distributor Facility Aware Date: 01/16/2015
• Device Age: 5 MO
• Date Report to Manufacturer: 01/23/2015
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other