MAUDE Adverse Event Report: KI MOBILITY, LLC. KI; ROGUE2

Model Number	ROGUE2
Medical Device Problem Code	Use of Device Problem (1670)
Health Effect - Clinical Code	Abrasion (1689)
Date of Event	06/29/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
After retrospective review of complaints, this report will be filed in abundance of caution because record was not reported.No additional information or communication with the end user after the initial report.Replacement parts were provided.After product returned the frame damage does not look like normal use.This is not a defective part.
Event or Problem Description
The end user was going down a hill and lost control and hit a bump and was launched from the chair.The end user had a facial fracture and lost some teeth, some bruising, and abrasions to her hands.Hospitalized for 3 days with monitoring and x-rays due to mouth trauma.

• Brand Name: KI
• Common Device Name: ROGUE2
• Manufacturer (Section D): KI MOBILITY, LLC.; 5201 woodward drive; stevens point WI 54481
• Manufacturer Contact: nancy elliott ; 5201 woodward drive; stevens point, WI 54481 ; 7155441784
• MDR Report Key: 24248835
• Report Number: 3005905321-2026-00001
• Device Sequence Number: 9970806
• Product Code: IOR
• UDI-Device Identifier: 00850013379323
• UDI-Public: 00850013379323
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K062660
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 02/02/2026

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: ROGUE2
• Device Catalogue Number: ROGUE2
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/26/2025
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/09/2024
• Initial Report FDA Received Date: 02/03/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/15/2024
• 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: Unknown
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization
• Patient Age: 16 YR
• Patient Sex: Female
• Patient Weight: 54 KG