MAUDE Adverse Event Report: RIFTON EQUIPMENT RIFTON GAIT TRAINER

Model Number K502

Device Problem Device Tipped Over (2589)

Patient Problems Fall (1848); Tooth Fracture (2428)

Event Date 04/13/2018

Event Type  Injury  

Event Description

According to the reporter, the student was in the gait trainer when she attempted to move forward and tipped the gait trainer over.The student reportedly hit her mouth on the floor and damaged a tooth.

• Brand Name: RIFTON GAIT TRAINER
• Type of Device: GAIT TRAINER
• 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: 7431397
• MDR Text Key: 105512176
• Report Number: 1319061-2018-00002
• Device Sequence Number: 1
• Product Code: ITJ
• 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
• Type of Report: Initial
• Report Date: 04/13/2018

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
• Device Operator: Physical Therapist
• Device Model Number: K502
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 03/13/2018
• Initial Date FDA Received: 04/13/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/07/2007
• 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): Other
• Patient Age: 9 YR
• Patient Weight: 24