MAUDE Adverse Event Report: C.T.M. TAIWAN MOTORIZED 3-WHEELED VEHICLE FOR OUTSIDE TRANSPORT; 890.3800

Model Number LEO-4B

Device Problem Break (1069)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Type  No Answer Provided  

Event Description

Per provider the seat hinge broke off where it bolts to the seat.

• Brand Name: MOTORIZED 3-WHEELED VEHICLE FOR OUTSIDE TRANSPORT
• Type of Device: 890.3800
• Manufacturer (Section D): C.T.M. TAIWAN; no. 33-12, lin 1; chiu tou village; taoyuan hsien 327 ; TW 327
• MDR Report Key: 4067274
• MDR Text Key: 18934496
• Report Number: 1531186-2014-03934
• 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: Manufacturer
• Source Type: Invalid Data
• Reporter Occupation: Medical Equipment Company Technician/Representative
• Type of Report: Initial
• Report Date: 09/08/2014,08/13/2014

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-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: 09/08/2014
• Distributor Facility Aware Date: 08/13/2014
• Device Age: 2 YR
• Date Report to Manufacturer: 09/08/2014
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 09/08/2014
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other