MAUDE Adverse Event Report: C.T.M. SHANGHAI MICROPORTABLE 3 WHEEL (RED) 9153645577; VEHICLE, MOTORIZED 3-WHEELED

Model Number L-3R

Device Problem Product Quality Problem (1506)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Type  malfunction  

Event Description

Dealer reported that the axle on a l-3r scooter has too much play, right to left, on the wheel.

• Brand Name: MICROPORTABLE 3 WHEEL (RED) 9153645577
• 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: 4353845
• MDR Text Key: 5204215
• Report Number: 1531186-2014-06697
• 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: 12/22/2014,12/02/2014

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: L-3R
• 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: 12/22/2014
• Distributor Facility Aware Date: 12/02/2014
• Device Age: 32 MO
• Date Report to Manufacturer: 12/22/2014
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other