MAUDE Adverse Event Report: RIFTON EQUIPMENT RIFTON TRICYCLE; ADAPTIVE TRICYCLE

Model Number	X330
Medical Device Problem Code	Improper or Incorrect Procedure or Method (2017)
Health Effect - Clinical Code	Limb Fracture (4518)
Date of Event	04/16/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the (b)(6) was riding the trike in a gym when he turned sharply and leaned the wrong way, causing the trike to tip.The user reportedly broke his elbow.

• Brand Name: RIFTON TRICYCLE
• Common Device Name: ADAPTIVE TRICYCLE
• Manufacturer (Section D): RIFTON EQUIPMENT; 103 woodcrest drive; rifton 12471
• Manufacturer (Section G): RIFTON EQUIPMENT; 103 woodcrest drive; rifton NY 12471
• Manufacturer Contact: travis scott ; 103 woodcrest drive; rifton, NY 12471 ; 8456587722
• MDR Report Key: 22099438
• Report Number: 1319061-2025-00003
• Device Sequence Number: 7356187
• Product Code: ION
• UDI-Device Identifier: 00850001752312
• UDI-Public: 00850001752312
• Combination Product (Y/N): N
• Initial Reporter State: WA
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Consumer
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 05/28/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Lay User/Patient
• Device Model Number: X330
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/28/2025
• Initial Report FDA Received Date: 05/28/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 6 YR
• Patient Sex: Male
• Patient Weight: 34 KG
• Patient Ethnicity: Hispanic