MAUDE Adverse Event Report: PERMOBIL INC. PERMOBIL M3; POWERED WHEELCHAIR

Model Number	M3
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Bone Fracture(s) (1870); Multiple Fractures (4519)
Date of Event	05/01/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
Reports while the end-user was in process of entering their transport vehicle via a ramp, the end-users foot reportedly came off of the footplate which subsequently became lodged into an immovable object resulting in injuries to the end-user requiring medical intervention to address.
Additional Manufacturer Narrative
This report was received in conjunction with a report submitted regarding an injury having occurred on 6/26/2024, and in that report it was mentioned of a previous adverse event having occurred on 5/1/2024, but was never reported.Initial report claimed the end-user had tendency to slide forward in the seating which allowed the end-users feet to fall off of the footplates during use of the device.Claims also were made of the end-user having some difficulty familiarizing themselves with the driving characteristics of a mid-wheel drive device.Report claimed as the end-user was traversing out of a transport vehicle via an incorporated ramp w/rails, the end-users foot fell off the footplate and became lodged on the handrail of the ramp.This resulted with the end-users right tibia/fibula becoming fractured.Premorbidly representative inspected the device with the va therapist with finding the device to remain fully operational with no signs of a malfunction having occurred.It was however noted the drive parameters were needing to be adjusted by lowering certain parameters to better meet the end-users needs by giving them better control of the device until they become more accustom to the driving characteristics.The va will be working with the end-user to provide better positioning aides to keep the end-user secure in the seating during use.The dhr was reviewed, and the device was found to have met specification prior to distribution.

• Brand Name: PERMOBIL M3
• Common Device Name: POWERED WHEELCHAIR
• Manufacturer (Section D): PERMOBIL INC.; 300 duke drive; lebanon TN 37090
• Manufacturer (Section G): PERMOBIL INC.; 300 duke drive; lebanon TN 37090
• Manufacturer Contact: kevin bullock ; 300 duke drive; lebanon, TN 37090 ; 8007360925
• MDR Report Key: 19812640
• Report Number: 1221084-2024-00013
• Device Sequence Number: 8891560
• Product Code: ITI
• UDI-Device Identifier: 17330818345674
• UDI-Public: 17330818345674
• Combination Product (Y/N): N
• Initial Reporter State: WY
• Initial Reporter Country: US
• PMA/510(K) Number: K123290
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Y
• Reporter Type: Manufacturer
• Report Source: Distributor
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 07/23/2024

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: M3
• Device Catalogue Number: N/A
• Device Lot Number: N/A
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/26/2024
• Initial Report FDA Received Date: 07/23/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/04/2023
• 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
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization
• Patient Sex: Prefer Not To Disclose