MAUDE Adverse Event Report: PERMOBIL INC. PERMOBIL M3 CORPUS; POWERED WHEELCHAIR

Model Number	M3 CORPUS
Medical Device Problem Codes	Mechanical Problem (1384); Unintended Collision (1429); Unintended System Motion (1430); Unintended Movement (3026)
Health Effect - Clinical Codes	Bruise/Contusion (1754); Laceration(s) (1946)
Date of Event	12/23/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Report claimed as the end-user was driving inside the home, they were witnessed as having removed their hand from the joystick, but the device reportedly continued to drive at speed, uncontrolled, until the device collided into a lower kitchen cabinet.The impact reportedly resulted with the end-user's toes sustaining multiple cuts and swelling.Ems was called due to amount of blood, and end-user was taken to local hospital for treatment of toe lacerations where they were released the same day.The device was evaluated by permobil representative where there were no signs of a product malfunction having occurred.Device was found to remain fully operational, and reports provided indicated the end-user had continued to utilize the device prior to permobils evaluation with no recurruring behaviour.Permobil was unable to confirm a product malfunction having occurred rendering a determination as to probable root cause unobtainable without speculation.The dhr was reviewed, and the device was found to have met specification prior to distribution.
Event or Problem Description
Received report claiming while the end-user was driving their device through the house, when they removed their hand from the joystick, alleges the device continued to drive at speed which caused the end-user to drive into a counter where they sustained injuries requiring medical intervention.

• Brand Name: PERMOBIL M3 CORPUS
• Common Device Name: POWERED WHEELCHAIR
• Manufacturer (Section D): PERMOBIL INC.; 300 duke drive; lebanon TN 37090
• Manufacturer (Section G): PERMOBIL AB; 300 duke drive; lebanon TN 37090
• Manufacturer Contact: ivan fernandez ; 300 duke drive; lebanon, TN 37090 ; 8007360925
• MDR Report Key: 21144744
• Report Number: 1221084-2025-00001
• Device Sequence Number: 18416298
• Product Code: ITI
• UDI-Device Identifier: 17330818345674
• UDI-Public: (01)17330818345674(11)240906
• Combination Product (Y/N): N
• Initial Reporter State: IN
• Initial Reporter Country: US
• PMA/510(K) Number: K123290
• 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): 01/13/2025

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: M3 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: 12/26/2024
• Initial Report FDA Received Date: 01/13/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/06/2024
• 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: Prefer Not To Disclose