MAUDE Adverse Event Report: MOBIUS MOBILITY LLC. IBOT PMD

Model Number	IBOT PMD
Health Effect - Clinical Code	Bone Fracture(s) (1870)
Date of Event	11/09/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
On (b)(6) 2022 or (b)(6) 2022, the user was building a trailer, and his foot slipped off the footplate.He did not notice, and then drove over his foot with the wheelchair.On (b)(6) 2022, he saw his therapist, who identified that the ankle was broken.User was not hospitalized and did not require surgical intervention - he is being treated as an outpatient.
Additional Manufacturer Narrative
The (b)(6) informed mobius mobility of this incident on (b)(6) 2022, and mobius staff spoke with her on 11/16/22 for further information.The therapist reports that the user has broken his foot/ankle several times previously with other devices.The therapist intends to update the user's seating components to better ensure that his feet remain on the footplate in the future, given his usage of the device.There is no reason to suspect that the device did not operate as intended - the cause of the injury is the user driving over his own foot.As limited medical intervention may have been needed to preclude permanent damage to a body structure, out of an abundance of caution mobius is considering this a "serious injury" and therefore submitting this report.

• 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 ; 6034258703
• MDR Report Key: 15898847
• Report Number: 3014522447-2022-00003
• Device Sequence Number: 5250966
• 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: Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 12/01/2022

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
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/20/2022
• Initial Report FDA Received Date: 12/01/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 03/23/2022
• 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: 30 YR
• Patient Sex: Male
• Patient Weight: 109 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White