MAUDE Adverse Event Report: RIFTON EQUIPMENT RIFTON TRICYCLE; ION EXERCISER, NON-MEASURING

Model Number UNKN

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Complaint, Ill-Defined (2331)

Event Date 11/27/2014

Event Type  Other  

Event Description

It was reported that a child fell off a rifton trike and got hurt.

Manufacturer Narrative

We understand that the child was not wearing a helmet at the time of the incident.The product guide and the product labels both say that helmet use is always required when using the trike.

• Brand Name: RIFTON TRICYCLE
• Type of Device: ION EXERCISER, NON-MEASURING
• Manufacturer (Section D): RIFTON EQUIPMENT; rifton NY
• Manufacturer Contact: travis scott ; 2032 rt 213; rifton, NY 12471 ; 8456587722
• MDR Report Key: 4392240
• MDR Text Key: 5437962
• Report Number: 1319061-2014-00002
• Device Sequence Number: 1
• Product Code: ION
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 12/19/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/22/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Model Number: UNKN
• Device Catalogue Number: UNKN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/24/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1