MAUDE Adverse Event Report: PERMOBIL INC. PERMOBIL M300 CORPUS HD; POWERED WHEELCHAIR

Model Number	M300 CORPUS HD
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	01/18/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Report indicates the end-users foot was positioned in such a way that a portion of the foot was hanging off the side of the footplate.When the end-user was attempting to maneuver the wheelchair through a doorway, the end-users foot caught the door frame which resulted in a fractured tibia.No claims or allegations were made of the device having malfunctioned or deviated in any way to have contributed to this event, with all accounts indicating inadvertent use error as being the cause.Reports indicate the device was operating normally at time of event, and continues to operate normally.The dhr was reviewed, and the device was found to have met specification prior to distribution.
Event or Problem Description
Reports while the end-user was maneuvering the device through a doorway, their foot contacted the door frame resulting in an injury requiring medical intervention to address. .

• Brand Name: PERMOBIL M300 CORPUS HD
• 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: 21274992
• Report Number: 1221084-2025-00003
• Device Sequence Number: 3942881
• Product Code: ITI
• UDI-Device Identifier: 17330818123401
• UDI-Public: (01)17330818123401(11)240222
• Combination Product (Y/N): N
• Initial Reporter State: TX
• 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: Distributor
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 01/30/2025

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: M300 CORPUS HD
• 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: 01/27/2025
• Initial Report FDA Received Date: 01/30/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 02/22/2024
• 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