MAUDE Adverse Event Report: PERMOBIL INC. PERMOBIL F5 CORPUS; POWERED WHEELCHAIR

Model Number	F5 CORPUS
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	07/04/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
Received report claiming as the end-user was exiting a home via a ramp that transitioned onto gravel pathway.Reports claims the device at some point lost traction which caused the end-user to lose control where the device reportedly slid down an embankment into a hole.Report indicates the end-user remained seated in the device and it remained upright throughout the event, but the drop into the hole reportedly resulted in injuries that required medical intervention to address.
Additional Manufacturer Narrative
Reports provided claim the device having appeared to have lost traction on a gravel pathway, and the end-user having reportedly lost control forcing the device to be maneuvered off the pathway where it slid down an embankment and landing into a hole that was approximately 10 inches in depth.Reports indicate the end-user remained seated in the device, and it remained upright throughout the event.The end-user was reported to have sustained fractures to the pelvis and upper portion of the femur as a result of the force of the impact when the device dropped into the hole.Reports indicate the end-user is currently seeking medical intervention for the injuries sustained.The device was evaluated by permobil representative and service provider to which the device was found to remain fully operational with no signs of a product malfunction having occurred.Reports provided claim the device had reportedly lost traction on the pathway and was presumed by witnesses that the end-user lost control and possibly over-compensated when attempting to correct with the joystick controls.Permobil was unable to re-create the loss of control as described, finding the device to react accordingly when given drive commands.Permobil is unable to determine a possible cause for this event without speculation.The dhr was reviewed, and the device was found to have met specification prior to distribution.

• Brand Name: PERMOBIL F5 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: 22630684
• Report Number: 1221084-2025-00009
• Device Sequence Number: 9074147
• Product Code: ITI
• UDI-Device Identifier: 17330818229844
• UDI-Public: (01)17330818229844(11)250623
• Combination Product (Y/N): N
• Initial Reporter State: TN
• Initial Reporter Country: US
• PMA/510(K) Number: K143014
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Y
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 07/28/2025

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: F5 CORPUS
• Device Catalogue Number: N/A
• Device Lot Number: N/A
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/11/2025
• Initial Report FDA Received Date: 07/28/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/23/2025
• 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