MAUDE Adverse Event Report: PERMOBIL INC. PERMOBIL F3 CORPUS; POWERED WHEELCHAIR

Model Number	F3 CORPUS
Medical Device Problem Codes	Mechanical Problem (1384); Unintended System Motion (1430); Unintended Movement (3026)
Health Effect - Clinical Codes	Bone Fracture(s) (1870); Multiple Fractures (4519)
Date of Event	05/16/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
Report of an event having occurred where it was claimed as the end-user was seated in their device near the entrance of their balcony, the wheelchair reportedly lunged forward without any input from the end-user, slamming the end-user's legs into a nearby chair.The impact reportedly resulted in injuries requiring medical intervention to address.
Additional Manufacturer Narrative
Permobil received correspondence from legal representative for the end-user where it was claimed the device having engaged a drive command without any physical manipulation given by the end-user.This reported action allegedly caused the device to drive forward and collide into an immovable object, reportedly resulting in bi-lateral tibia fractures.At this time, permobil has been unable to inspect or evaluate the device to confirm a product malfunction has occurred as alleged, thus is unable to reach a determination as to possible root cause without speculation.If any new information is received, a follow-up report will be submitted.The dhr was reviewed, and the device was found to have met specification prior to distribution.

• Brand Name: PERMOBIL F3 CORPUS
• 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: 23923617
• Report Number: 1221084-2025-00019
• Device Sequence Number: 9338478
• Product Code: ITI
• UDI-Device Identifier: 17330818676433
• UDI-Public: (01)17330818676433(11)200702
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K143180
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Y
• Reporter Type: Manufacturer
• Report Source: Other
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 12/30/2025

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: F3 CORPUS
• Device Catalogue Number: N/A
• Device Lot Number: N/A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/10/2025
• Initial Report FDA Received Date: 12/30/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 07/02/2020
• 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: Unknown