MAUDE Adverse Event Report: C.T.M. SHANGHAI MICROPORTABLE 4 WHEEL (BLUE) 9153645579; VEHICLE, MOTORIZED 3-WHEELED

Model Number L-4B

Device Problem Device Inoperable (1663)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Type  malfunction  

Event Description

Dealer is stating that they received this motor brake as received with broken plastic pieces by the lever.Dealer is stating that the motor was wrapped in bubble wrap except for the portion that was received broken.

• Brand Name: MICROPORTABLE 4 WHEEL (BLUE) 9153645579
• 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: 4518453
• MDR Text Key: 17264158
• Report Number: 1531186-2015-00984
• 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: 02/13/2015,02/09/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/16/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: L-4B
• 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: 02/13/2015
• Distributor Facility Aware Date: 02/09/2015
• Device Age: 22 MO
• Date Report to Manufacturer: 02/13/2015
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other