MAUDE Adverse Event Report: FULL VISION, INC. TREADMILL; TREADMILL, POWERED

Model Number TM2100 ST

Device Problem Unintended Movement (3026)

Patient Problem Fall (1848)

Event Date 04/25/2023

Event Type  Injury  

Event Description

This letter is to inform you of an event that occurred at (b)(6) in colombia on (b)(6) 2023, in which it was alleged the treadmill (tm2100st) belt began moving without user interaction while the patient was on it.The patient fell which resulted in injuries and hospitalization.This report reflects information received by fda in the form of a notification per 803.22 (b)(2).

• Brand Name: TREADMILL
• Type of Device: TREADMILL, POWERED
• Manufacturer (Section D): FULL VISION, INC.
• MDR Report Key: 17488582
• MDR Text Key: 320685081
• Report Number: MW5121281
• Device Sequence Number: 1
• Product Code: IOL
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 05/04/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/09/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Device Model Number: TM2100 ST
• Patient Sequence Number: 1