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

Model Number	F3 CORPUS
Medical Device Problem Code	Use of Device Problem (1670)
Health Effect - Clinical Codes	Abrasion (1689); Burn(s) (1757); Full thickness (Third Degree) Burn (2696)
Date of Event	12/23/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Information provided to service provider from the end-user claims as the end-user was driving down a ramp on the street outside of the local hospital, they inadvertently struck a brick that was laying in the road.This reportedly caused the device to become unstable and fall over on to its side, with the end-user in the seating.Reports claim the wheelchairs joystick was still being activated allowing the drive wheels to spin while laying on its side.Reports indicate the end-user's leg was resting against the spinning drive wheel which caused 3rd degree burns to their leg due to the friction of the tire against the skin.The end-user made no claims or allegations that the device malfunctioned or deviated in operation in any way to have contributed to this event.The device was evaluated and was found to remain fully operational with some minor damages to subcomponents which are being attributed to the wheelchair falling on its side.The dhr was reviewed, and the device was found to have met specification prior to distribution.
Event or Problem Description
Received report indicating as the end-user was driving their wheelchair outside of a local hospital, after exiting a ramp, the wheelchair struck a brick that was in the road which reportedly caused the wheelchair to lose upright stability and fall over on to its side, with the end-user.Reports indicate the event resulted in injuries to the end-user which required medical intervention to address.

• 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: kevin bullock ; 300 duke drive; lebanon, TN 37090 ; 8007360925
• MDR Report Key: 13478744
• Report Number: 1221084-2022-00004
• Device Sequence Number: 5147427
• Product Code: ITI
• UDI-Device Identifier: 17330818676433
• UDI-Public: 17330818676433
• Combination Product (Y/N): N
• Initial Reporter State: LA
• 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: Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 02/08/2022

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?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/19/2022
• Initial Report FDA Received Date: 02/08/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 08/17/2021
• 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: Female
• Patient Weight: 113 KG