MAUDE Adverse Event Report: MOBIUS MOBILITY LLC. IBOT PMD

Model Number	IBOT PMD
Medical Device Problem Code	Use of Device Problem (1670)
Health Effect - Clinical Code	Limb Fracture (4518)
Date of Event	10/21/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Mobius mobility assistive technology professional (atp) met with the user on (b)(6) 2025 and had access to the device for investigation.The atp reviewed what happened when his ankles were injured and what additional could be done to help prevent it in the future.This is the users 2nd event of running over their feet (see report number: 3014522447-2025-00005).The user was interviewed by the mobius mobility service team and indicated that he was not using the positioning strap at the time of this event.The user did not indicate he had any issues with the ibot nor did the atp find any issues on (b)(6) 2025.Mobius mobility reviewed the user's original device configuration and the history of support call and parts requests from the user.The user adjusted their thigh guides, so they stuck out the front, and started using a positioning strap around their legs ((b)(6) 2025).
Event or Problem Description
An ibot user called to report that he had an incident at approximately 11am on (b)(6) when he ran over his right foot, resulting in the breaking of 2 bones (bimalleolar ankle fracture).

• Brand Name: IBOT PMD
• Common Device Name: IBOT
• Manufacturer (Section D): MOBIUS MOBILITY LLC.; 540 north commercial st.; suite 310; manchester NH 03101
• Manufacturer (Section G): MOBIUS MOBILITY LLC.; 540 n. commercial street; suite 310; manchester NH 03101
• Manufacturer Contact: joseph sullivan ; 540 n. commercial street; suite 310; manchester, NH 03101 ; 8333464268
• MDR Report Key: 23524612
• Report Number: 3014522447-2025-00009
• Device Sequence Number: 21379165
• Product Code: IMK
• UDI-Device Identifier: 00857584008010
• UDI-Public: 00857584008010
• Combination Product (Y/N): N
• Initial Reporter State: NH
• Initial Reporter Country: US
• PMA/510(K) Number: K210920
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Consumer
• Initial Reporter Occupation: Other
• Remedial Action: Modification/Adjustment
• Type of Report: Initial
• Report Date (Section B): 11/11/2025

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
• Operator of Device: Lay User/Patient
• Device Model Number: IBOT PMD
• Device Catalogue Number: MMPX-10000-000
• Device Lot Number: N/A
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/22/2025
• Initial Report FDA Received Date: 11/11/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/15/2024
• 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
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 61 YR
• Patient Sex: Male
• Patient Weight: 84 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White