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

Model Number M CORPUS VS

Device Problem Use of Device Problem (1670)

Patient Problem Bone Fracture(s) (1870)

Event Date 11/28/2023

Event Type  Injury  

Event 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.

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
• Type of Device: 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
• MDR Text Key: 336737800
• Report Number: 1221084-2024-00003
• Device Sequence Number: 1
• Product Code: IPL
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K191874
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Company Representative
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 03/01/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/01/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: 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
• Date Manufacturer Received: 11/22/2023
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 08/21/2023
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization
• Patient Sex: Prefer Not To Disclose