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

Model Number	M3 CORPUS
Medical Device Problem Codes	Mechanical Problem (1384); Mechanical Jam (2983)
Health Effect - Clinical Codes	Fall (1848); Laceration(s) (1946); Tooth Fracture (2428)
Date of Event	04/27/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Report was received from the end-user's sister reporting the end-user having fallen out of the power wheelchair on numerous occasions, with claims the caster wheels are becoming stuck in cracks in the sidewalk, and this is causing the powerchair to become blocked while in motion, and this has caused the end-user to fall out of the seating.The most recent event reportedly led to the end-user sustaining a chipped tooth, broken nose, and split lip requiring stiches.The end-user was unable to be reached by permobil, and the provider stated they had not received any communication from the end-user related to any issues with the device related to control or stability issues.At time of this report, the device has not been evaluated to determine if a product malfunction occurred.The provider is making arrangements with the end-user to inspect the device.If permobil receives any new information, a follow-up report will be submitted.The dhr was reviewed, and the device was found to have met specification prior to distribution.
Event or Problem Description
Received report claiming while driving the m3 corpus device down a sidewalk, claims were made that the front caster wheels rotated sideways and became stuck in a crack on the pavement.This reportedly caused the device to lose forward momentum which reportedly forced the end-user to lose positioning and fall out of the seating to ground.The fall was reported to have resulted in injuries requiring medical intervention to address.

• 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 INC.; 300 duke drive; lebanon TN 37090
• Manufacturer Contact: ivan fernandez ; 300 duke drive; lebanon, TN 37090 ; 8007360925
• MDR Report Key: 22145664
• Report Number: 1221084-2025-00006
• Device Sequence Number: 12864065
• Product Code: ITI
• UDI-Device Identifier: 17330818345674
• UDI-Public: (01)17330818345674(11)220630
• Combination Product (Y/N): N
• 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): 06/04/2025

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?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/09/2025
• Initial Report FDA Received Date: 06/04/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 06/30/2022
• 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: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization
• Patient Sex: Unknown