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

Model Number	F5 Corpus
Medical Device Problem Codes	Mechanical Problem (1384); Unintended System Motion (1430); Unintended Movement (3026)
Health Effect - Clinical Codes	Spinal Cord Injury (2432); Nervous System Injury (2689)
Date of Event	02/12/2023
Type of Reportable Event	Serious Injury

• Brand Name: 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 ; +1(800)736-0925
• MDR Report Key: 50889313
• Report Number: 1221084-2026-00046
• Device Sequence Number: 13209357
• Product Code: ITI
• UDI-Device Identifier: 17330818229844
• UDI-Public: (01)17330818229844(11)191014
• Combination Product (Y/N): N
• Initial Reporter State: CO
• 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: Other
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 09/24/2026

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
• Device Catalogue Number: n/a
• Device Lot Number: n/a
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/04/2026
• Initial Report FDA Received Date: 09/24/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 10/14/2019
• 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: Required Intervention
• Patient Sex: Unknown