MAUDE Adverse Event Report: MOBIUS MOBILITY LLC. IBOT PMD

Model Number	IBOT PMD
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Damage to Ligament(s) (1952)
Date of Event	06/25/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
The user was operating the ibot® pmd in a crosswalk in 4-wheel mode.The user began crossing the street while the traffic signal was red.When she was about to cross in front of a semi-truck from the passenger side, the traffic light changed to green for vehicle traffic and the truck began to move forward.Surveillance footage shows the user waved her arm to attempt to get the driver's attention, but the truck did not stop.The truck collided with the user at a fairly low speed and pushed her about 15 feet further into the intersection.The device did not tip over, and the user remained in the seat.The user sustained a sprained knee and ankle and was brought to the hospital out of an abundance of caution.
Additional Manufacturer Narrative
Blackbox and ecf data and video were retrieved and evaluated.As the device did not tip over, an event log was not created for the incident.There were no diagnostic codes present in the data, indicating there were no issues with the ibot® pmd at the time of the event.There is no indication that the ibot® pmd contributed to the incident, nor is there evidence of any malfunction or issue with the device at the time of the incident.

• 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: 22534784
• Report Number: 3014522447-2025-00006
• Device Sequence Number: 7409993
• 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: Replace
• Type of Report: Initial
• Report Date (Section B): 07/17/2025

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: 06/26/2025
• Initial Report FDA Received Date: 07/17/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/16/2020
• 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: Hospitalization
• Patient Age: 51 YR
• Patient Sex: Female
• Patient Weight: 102 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White