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

Model Number	M3
Medical Device Problem Code	Use of Device Problem (1670)
Health Effect - Clinical Codes	Bone Fracture(s) (1870); Limb Fracture (4518)
Date of Event	03/25/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Service provider reports having inspected the device, and determined it to remain fully operational with no signs of a malfunction having occurred.The end-user reported having misjudged their proximity of the device to the doorway opening, and impacted their leg into the door frame while attempting to traverse through the opening.Report indicates the end-user sustained an fx to their right tibia as a result.The end-user made no claims or allegations of the device having malfunctioned or deviated in any way to have contributed to this event.The dhr was reviewed, and the device was found to have met specification prior to distribution.
Event or Problem Description
Received report stating while the end-user was maneuvering their device through a doorway, they inadvertently impacted the doorframe with the device, resulting in an injury requiring medical intervention.

• Brand Name: PERMOBIL M3
• 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: kevin bullock ; 300 duke drive; lebanon, TN 37090 ; 8007360925
• MDR Report Key: 19070182
• Report Number: 1221084-2024-00008
• Device Sequence Number: 12487972
• Product Code: ITI
• UDI-Device Identifier: 17330818345674
• UDI-Public: 17330818345674
• Combination Product (Y/N): N
• Initial Reporter State: CO
• 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): 04/09/2024

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
• 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: 03/26/2024
• Initial Report FDA Received Date: 04/09/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 10/10/2022
• 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: Prefer Not To Disclose