MAUDE Adverse Event Report: PERMOBIL INC. PERMOBIL M CORPUS VS; POWERED WHEELCHAIR

Model Number	M CORPUS VS
Medical Device Problem Code	Use of Device Problem (1670)
Health Effect - Clinical Code	Bone Fracture(s) (1870)
Date of Event	11/28/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
Reports while end-user was navigating their power wheelchair through a restaurant, the end-users foot caught the corner of a wall forcing their leg to rotate backward.This event resulted in an injury requiring medical intervention to address.
Additional Manufacturer Narrative
Report provided from end-user claimed as they were maneuvering their power wheelchair through a restaurant, their foot was slightly off the footplate and their toe caught the corner of a wall and externally rotated their foot backwards (180 degrees), resulting in a fracture to the left fibula.The end-user stated they misjudged the proximity of the device to the wall, and did not make any claims or allegations of the device having malfunctioned or deviated in any fashion to have contributed to this event.The dhr was reviewed, and the device was found to have met specification prior to distribution.

• Brand Name: PERMOBIL M CORPUS VS
• 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: ivan fernandez ; 300 duke drive; lebanon, TN 37090 ; 8007360925
• MDR Report Key: 18822447
• Report Number: 1221084-2024-00003
• Device Sequence Number: 4462205
• Product Code: IPL
• UDI-Device Identifier: 17330818002003
• UDI-Public: 17330818002003
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K191874
• 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: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 03/01/2024

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: M CORPUS VS
• Device Catalogue Number: N/A
• Device Lot Number: N/A
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/22/2023
• Initial Report FDA Received Date: 03/01/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 08/21/2023
• 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