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

Model Number R130

Device Problem Use of Device Problem (1670)

Patient Problem Multiple Fractures (4519)

Event Date 12/01/2022

Event Type  Injury  

Event Description

It was reported that a user was using the trike in the gym with a staff member walking along side.The reporter believes the staff member fell and pulled the trike over onto themselves, breaking some bones.The user was unhurt.

• Brand Name: RIFTON TRICYCLE
• Type of Device: ADAPTIVE TRICYCLE
• Manufacturer (Section D): RIFTON EQUIPMENT; 103 woodcrest drive; rifton NY 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: 16061123
• MDR Text Key: 306263853
• Report Number: 1319061-2022-00007
• 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: User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 12/28/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/28/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: R130
• Device Catalogue Number: R130
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/01/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/04/2001
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 11 YR
• Patient Sex: Female
• Patient Weight: 45 KG