MAUDE Adverse Event Report: C.T.M. TAIWAN SCOOTER MIDSIZE 4-WHEEL SILVER 9153650474; VEHICLE, MOTORIZED 3-WHEELED

Model Number LEO-4S

Device Problem Break (1069)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Type  malfunction  

Event Description

Dealer is stating that while the end user was riding her scooter the tread fell off the wheel on the rear tire.

• Brand Name: SCOOTER MIDSIZE 4-WHEEL SILVER 9153650474
• 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: 4353258
• MDR Text Key: 5146087
• Report Number: 1531186-2014-06617
• 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: Distributor
• Source Type: Invalid Data
• Reporter Occupation: Medical Equipment Company Technician/Representative
• Type of Report: Initial
• Report Date: 12/19/2014,12/02/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/22/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: LEO-4S
• 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: 12/19/2014
• Distributor Facility Aware Date: 12/02/2014
• Device Age: 2 YR
• Date Report to Manufacturer: 12/19/2014
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other