MAUDE Adverse Event Report: KI MOBILITY KI MOBILITY; ROGUE2

Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581)
Date of Event	06/28/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
We have requested the device be returned.We are unable to verify a defect at this time.Will submit an update if we receive the part for evaluation.
Event or Problem Description
The end user was going up a ramp and fell back.End user stated she fell back and hit head on concrete.

• Brand Name: KI MOBILITY
• Common Device Name: ROGUE2
• Manufacturer (Section D): KI MOBILITY; 5201 woodward dr; stevens point WI 54481
• Manufacturer Contact: kathy wirtz ; 5201 woodward dr; atevens point, WI 54481
• MDR Report Key: 22576491
• Report Number: 3005905321-2025-00005
• Device Sequence Number: 15834870
• Product Code: IOR
• UDI-Device Identifier: 00850013379323
• UDI-Public: (01)00850013379323(11)2025-04-24
• Combination Product (Y/N): N
• Initial Reporter State: MN
• 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: Other
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 07/23/2025

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
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 07/23/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown