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

Model Number	ROGUE2
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Codes	Bruise/Contusion (1754); Swelling/ Edema (4577)
Date of Event	08/15/2025
Type of Reportable Event	Malfunction
Event or Problem Description
Dealer states that the camber tube assembly snapped on the end users chair while in the chair.He was in chair going down his hallway when the camber tube snapped and he fell out of chair injuring his right inside elblow.He went to the er on friday, (b)(6) 2025.Injury reported on (b)(6) 2025.

• Brand Name: KI MOBILITY, LLC
• Common Device Name: ROGUE2
• 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: nancy elliott ; 5201 woodward drive; stevens point, WI 54481 ; 7155441784
• MDR Report Key: 22921437
• Report Number: 3005905321-2025-00006
• Device Sequence Number: 10389652
• Product Code: IOR
• UDI-Device Identifier: 00850013379323
• UDI-Public: (01)00850013379323(11)2024-01-29
• Combination Product (Y/N): N
• Initial Reporter State: GA
• Initial Reporter Country: US
• 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: Distributor
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 08/28/2025

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
• Operator of Device: Lay User/Patient
• Device Model Number: ROGUE2
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 08/25/2025
• Initial Report FDA Received Date: 08/29/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 01/29/2024
• 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
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Age: 48 YR
• Patient Sex: Male
• Patient Weight: 109 KG