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	05/09/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Mobius mobility made multiple requests for access to the device for investigation, but it was not made available.The user was interviewed by the mobius mobility service team.The user did not indicate he had any issues with the ibot.Mobius mobility reviewed the user's original device configuration and the history of support calls and parts requests from the user.The user had a fixed center mount foot platform with calfpads and rubber coated adjustable angle foot plate (11.5 inch x 10 inch).The device also had lateral thigh supports that had been adjusted to provide distal support at his knees.There were no leg straps on the order and there were no calls from the user indicating that they were having issues keeping their feet on the foot plate.In reviewing the training record with the assistive technology professional that performed the training, the user had no issues keeping his feet on the foot plate when maneuvering in standard, 4-wheel, balance, or stair modes.The user had, after delivery, reversed the lateral thigh supports making them more proximally positioned and this adjustment could result in the lack of foot/leg control when using the device, contributing to the incident.
Event or Problem Description
User was driving ibot® pmd on the sidewalk and their foot slipped off the footplate resulting in the user driving over their own ankle.The event resulted in a fractured ankle.

• 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: 22169838
• Report Number: 3014522447-2025-00005
• Device Sequence Number: 7829333
• 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): 06/09/2025

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: 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: 05/15/2025
• Initial Report FDA Received Date: 06/09/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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