MAUDE Adverse Event Report: C.T.M. TAIWAN SCOOTER MIDSIZE 3 WHEEL SILVER 9153652403; VEHICLE, MOTORIZED 3-WHEELED

Model Number PEGASUS4R-8

Device Problem Break (1069)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 01/05/2015

Event Type  malfunction  

Event Description

Dealer states, broken weldment on front frame pegasus.

• Brand Name: SCOOTER MIDSIZE 3 WHEEL SILVER 9153652403
• Type of Device: VEHICLE, MOTORIZED 3-WHEELED
• Manufacturer (Section D): C.T.M. TAIWAN; no. 33-12, lin 1; chiu tou village; taoyuan hsien 327 ; TW 327
• MDR Report Key: 4425107
• MDR Text Key: 5167868
• Report Number: 1531186-2015-00297
• Device Sequence Number: 1
• Product Code: INI
• Combination Product (y/n): N
• Reporter Country Code: CA
• 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: 01/14/2015,01/05/2015

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: PEGASUS4R-8
• 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: 01/14/2015
• Distributor Facility Aware Date: 01/05/2015
• Date Report to Manufacturer: 01/14/2015
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 01/16/2015
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other