RIFTON TRICYCLE R14

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a user facility report with the FDA on 2019-04-27 for RIFTON TRICYCLE R14 manufactured by Rifton Equipment.

Event Text Entries

[145114925] It was reported that the wheel fell off a rifton trike. It appears that the axle bearing may have seized up, eventually wearing through the axle.
Patient Sequence No: 1, Text Type: D, B5

MAUDE Entry Details

• Report Number: 1319061-2019-00033
• MDR Report Key: 8559431
• Report Source: USER FACILITY
• Date Received: 2019-04-27
• Date of Report: 2019-04-27
• Date of Event: 2019-03-28
• Date Mfgr Received: 2019-03-28
• Device Manufacturer Date: 2003-02-27
• Date Added to Maude: 2019-04-27
• Event Key: 0
• Report Source Code: Manufacturer report
• Manufacturer Link: Y
• Number of Patients in Event: 0
• Adverse Event Flag: 3
• Product Problem Flag: 3
• Reprocessed and Reused Flag: 3
• Health Professional: 3
• Initial Report to FDA: 3
• Report to FDA: 3
• Event Location: 3
• Manufacturer Contact: MR. TRAVIS SCOTT
• Manufacturer Street: 103 WOODCREST DRIVE
• Manufacturer City: RIFTON NY 12471
• Manufacturer Country: US
• Manufacturer Postal: 12471
• Manufacturer Phone: 8456587722
• Manufacturer G1: RIFTON EQUIPMENT
• Manufacturer Street: 103 WOODCREST DRIVE
• Manufacturer City: RIFTON NY 12471
• Manufacturer Country: US
• Manufacturer Postal Code: 12471
• Single Use: 3
• Previous Use Code: 3
• Event Type: 3
• Type of Report: 3

Device Details

• Brand Name: RIFTON TRICYCLE
• Generic Name: ADAPTIVE TRICYCLE
• Product Code: ION
• Date Received: 2019-04-27
• Model Number: R14
• Catalog Number: R14
• Operator: LAY USER/PATIENT
• Device Availability: N
• Device Eval'ed by Mfgr: R
• Device Sequence No: 1
• Device Event Key: 0
• Manufacturer: RIFTON EQUIPMENT
• Manufacturer Address: 103 WOODCREST DRIVE RIFTON NY 12471 US 12471

Patients

Patient Number	Treatment	Outcome	Date
1	0		2019-04-27