MAUDE Adverse Event Report: MOBIUS MOBILITY LLC. IBOT PMD

Model Number IBOT PMD

Device Problem Insufficient Information (3190)

Patient Problem Bone Fracture(s) (1870)

Event Date 11/09/2022

Event Type  Injury  

Event 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.

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
• Type of Device: 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
• MDR Text Key: 304682446
• Report Number: 3014522447-2022-00003
• Device Sequence Number: 1
• Product Code: IMK
• UDI-Device Identifier: 00857584008010
• UDI-Public: 00857584008010
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K210920
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 12/01/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/01/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: 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
• Date Manufacturer Received: 07/20/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/23/2022
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 30 YR
• Patient Sex: Male
• Patient Weight: 109 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White