MAUDE Adverse Event Report: C.T.M. SHANGHAI SCOOTER MIDSIZE 3 WHEEL BLUE 9153652394; VEHICLE, MOTORIZED 3-WHEELED

Model Number LEO-3B

Device Problem Break (1069)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Type  malfunction  

Event Description

Where lever is, the post that comes out of the switch just snapped off.

• Brand Name: SCOOTER MIDSIZE 3 WHEEL BLUE 9153652394
• Type of Device: VEHICLE, MOTORIZED 3-WHEELED
• Manufacturer (Section D): C.T.M. SHANGHAI; 1158 yuan qu road; anting town; shanghai 2018 05; CH 201805
• MDR Report Key: 4365589
• MDR Text Key: 5113516
• Report Number: 1531186-2014-06979
• 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: 12/29/2014,12/04/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: LEO-3B
• 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: 12/29/2014
• Distributor Facility Aware Date: 12/04/2014
• Date Report to Manufacturer: 12/29/2014
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 12/29/2014
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other