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

Model Number L-3R

Device Problem Device Inoperable (1663)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Type  malfunction  

Event Description

Doug states he purchased this lynx3-r second hand.He states the component that makes the scooter goes forward or backward is broken, intermittent contact.Referred to dealer in his area for parts.

• 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: 4518477
• MDR Text Key: 5408693
• Report Number: 1531186-2015-00989
• 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: Patient
• 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-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: 02/13/2015
• Distributor Facility Aware Date: 02/09/2015
• 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