MAUDE Adverse Event Report: PERMOBIL INC. PERMOBIL 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); Damage to Ligament(s) (1952)
Date of Event	03/01/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The area permobil representative had accompanied the service provider to set-up and finalize the positioning of the seating and programming of the stand feature of the device to meet the clients needs.After confirming positioning was appropriate, the seating was raised into a stand position, all the while inquiring from the end-user to report any discomfort.Reports indicate upon the second attempt to stand, the end-user claimed feeling some pain in their right knee.They were immediately lowered to a seated position and the area of reported pain was inspected but did not reveal any notable signs of trauma having occurred.After re-verifying positioning was correct, the standing procedure resumed with the end-user reporting of pain in the same location of their right knee.At this time, all standing was stopped, and end-user was advised to contact their physician.The end-user reported having had x-rays performed where it was determined they had sustained a fracture to their right tibia and torn acl.Prior to the fitting, the end-user reportedly conferred with their physician to gain clearance to resume using stand therapy after having suffered previous leg fractures that were sustained approximately 6 months prior as the result of an auto accident.Permobil is unable to conclude a root cause for the injury without speculation.However, has determined the device was fully operational with reports indicating the positioning of the seating was appropriate for the end-user at the time the incident was reported to have occurred.The dhr was reviewed and the device was found to have met specification prior to distribution.
Event or Problem Description
Received report claiming during the final fitting and set up of the standing seating function on the device, the end-user reported having some pain in their right leg.The end-user reported having sought medical intervention where it was determined they had sustained a fractured tibia and damaged acl.

• Brand Name: PERMOBIL F5 CORPUS VS
• Common Device Name: POWERED WHEELCHAIR
• Manufacturer (Section D): PERMOBIL INC.; 300 duke drive; lebanon TN 37090
• MDR Report Key: 11603494
• Report Number: 1221084-2021-00009
• Device Sequence Number: 17231360
• Product Code: ITI
• UDI-Device Identifier: 17330818001006
• UDI-Public: 17330818001006
• Combination Product (Y/N): N
• Initial Reporter State: MN
• 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: distributor
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 04/01/2021

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
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/10/2021
• Initial Report FDA Received Date: 04/01/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Weight: 70