MAUDE Adverse Event Report: Permobil Inc. F5 Corpus VS; Powered Wheelchair

Model Number	F5 Corpus VS
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Bone Fracture(s) (1870); Limb Fracture (4518)
Date of Event	06/13/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
Reports while using the f5 corpus vs wheelchair in the community, the end-user reported at one point it became tippy and they fell out of the seating to the ground where they sustained a serious injury requiring medical intervention to address.
Additional Manufacturer Narrative
Permobil representative received report that the f5 corpus vs was provided to the end-user, by their provider, as a loaner while their current device was being serviced.This device was a permobil demo and was provided to the end-user without permobil's knowledge.The end-user claims while driving the device in their community, the device reportedly became tippy which caused the end-user to lose positioning and fall out of the seating to the ground where they sustained an injury to their leg.Reports claim the injury was too severe to mend which required amputation of the left leg to address.The end-user reported their weight at time of event was 380 lbs.And the maximum recommended weight for the f5 corpus vs is 330 lbs.The end-user reports the f5 corpus vs was just dropped off at the end-user's home and was not adjusted or fitted to meet their physical dimensions, and the provided positioning belt was too short to extend around the end-user thus was unable to be used.The device was evaluated by permobil representative and was found to remain fully operational with no signs of a malfunction having occurred.It is permobil's contention the root cause for this event was unrelated to a device malfunction, but rather a device being provided that was inadequate for the end-user due to exceeding weight capacity, improperly fitted, and access to use of a standing feature without any training or prior authorization from their physician.

• Brand Name: F5 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 ; +1(800)736-0925
• MDR Report Key: 50069860
• Report Number: 1221084-2026-00016
• Device Sequence Number: 10287562
• Product Code: IPL
• UDI-Device Identifier: 17330818001006
• UDI-Public: (01)17330818001006(11)220818
• Combination Product (Y/N): N
• Initial Reporter State: TN
• 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): Y
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 07/29/2026

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 VS
• Device Catalogue Number: n/a
• Device Lot Number: n/a
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/14/2026
• Initial Report FDA Received Date: 07/29/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/18/2022
• 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: Reuse
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Disability; Hospitalization
• Patient Sex: Unknown