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

Model Number	F5 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	05/12/2026
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The end-user reported having an incident where they described the positioning belt having fallen to the side and was under the drive wheel.When the end-user reached down to pick it up, they reportedly lost their balance and fell forward.When that occurred, they report their shirt had caught the joystick knob and forced the chair to engage a drive command where it drove over them and into a door, eventually stopping with the chair atop the end-user.This resulted in the end-user having sustained a fracture to their left tibia requiring medical intervention to address.The end-user reports they are still using the device, and when asked if the device operated differently to have led to the event, they stated the device was operating normally and remains to operate normally nor did they make any claim or allegation of the device having malfunctioned to have contributed to the event.The dhr was reviewed, and the device was found to have met specification prior to distribution.
Event or Problem Description
Reports having an incident where they described the positioning belt having fallen to the side and was under the drive wheel.When the end-user reached down to pick it up, they reportedly lost their balance and fell forward.When that occurred, they report their shirt had caught the joystick knob and forced the chair to engage a drive command where it drove over them and into a door, eventually stopping with the chair atop the end-user.This resulted in the end-user having sustained an injury requiring medical intervention to address.

• Brand Name: PERMOBIL 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 ; 8007360925
• MDR Report Key: 25355121
• Report Number: 1221084-2026-00008
• Device Sequence Number: 13425408
• Product Code: IPL
• UDI-Device Identifier: 17330818001006
• UDI-Public: (01)17330818001006(11)220221
• Combination Product (Y/N): N
• Initial Reporter State: LA
• 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: Consumer
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 06/01/2026

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 VS
• Device Catalogue Number: N/A
• Device Lot Number: N/A
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/18/2026
• Initial Report FDA Received Date: 06/01/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 02/21/2022
• 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: Hospitalization
• Patient Sex: Unknown