MAUDE Adverse Event Report: C.T.M. SHANGHAI SCOOTER MIDSIZE 4-WHEEL BLUE 9153650475; VEHICLE, MOTORIZED 3-WHEELED

Model Number LEO-4S

Device Problem Break (1069)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 01/12/2015

Event Type  malfunction  

Event Description

Provider states the handle broke on the scooter.Provider chose the part he needed from the leo-4s web parts page, part 1169008 the throttle lever.Provider was advised non warranty.Provider states no property damage or injury alleged, no further information provided.

• Brand Name: SCOOTER MIDSIZE 4-WHEEL BLUE 9153650475
• 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: 4459902
• MDR Text Key: 16173677
• Report Number: 1531186-2015-00618
• 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: 01/27/2015,01/21/2015

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-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: 01/27/2015
• Distributor Facility Aware Date: 01/21/2015
• Device Age: 2 YR
• Date Report to Manufacturer: 01/27/2015
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 01/28/2015
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other