MAUDE Adverse Event Report: KI MOBILITY, LLC KI MOBILITY, LLC; ROGUE 2

Model Number	ROGUE 2
Medical Device Problem Code	Material Split, Cut or Torn (4008)
Health Effect - Clinical Code	Loss of consciousness (2418)
Date of Event	10/13/2025
Type of Reportable Event	Malfunction
Event or Problem Description
Dealer claims the back upholstery broke away from the back tubes and 2 attaching screws on the tension adjustable back upholstery and the client fell backward, hit the wall and broke thru the sheet rock and was unconscious, client was on the floor for an hour until parent came to get him.The end user was going from hall way into his bedroom.As he was propelling, pressure was put on the back rest and he is paralyzed and did not feel the upholstery sliding down.

• Brand Name: KI MOBILITY, LLC
• Common Device Name: ROGUE 2
• Manufacturer (Section D): KI MOBILITY, LLC; 5201 woodward drive; stevens point WI 54481
• Manufacturer (Section G): KI MOBILITY, LLC; 5201 woodward drive; stevens point WI 54481
• Manufacturer Contact: jason rusch ; 5201 woodward drive; stevens point, WI 54481 ; 7153036438
• MDR Report Key: 23622082
• Report Number: 3005905321-2025-00007
• Device Sequence Number: 15721421
• Product Code: IOR
• UDI-Device Identifier: 00850013379323
• UDI-Public: (01)00850013379323(11)2023-12-14
• Combination Product (Y/N): N
• Initial Reporter State: NC
• Initial Reporter Country: US
• PMA/510(K) Number: K223527
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Distributor
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 11/14/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Model Number: ROGUE 2
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 11/13/2025
• Initial Report FDA Received Date: 11/21/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 12/14/2023
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Age: 40 YR
• Patient Sex: Male
• Patient Weight: 64 KG