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

Model Number	M3
Medical Device Problem Codes	Mechanical Problem (1384); Unintended Collision (1429); Unintended Movement (3026)
Health Effect - Clinical Code	Bone Fracture(s) (1870)
Date of Event	02/01/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Report provided to permobil from the end-user claims while attempting to enter their apartment, they drove the wheelchair into the frame of the apartment door, resulting in a broken finger.The end-user reports this event occurred approximately 8-9 months prior but had not reported to permobil until just recently.The end-user claims the wheelchair "wiggles" and that is what caused them to drive into the door frame.The end-user claims having contacted their service provider numerous times, but due to covid restrictions, they never responded.Permobil contacted the end-user's service provider and was informed they would schedule to evaluate the device.At the time, permobil is unable to confirm a product malfunction as the service provider has been unable to evaluate the device due to scheduling issues with the end-user.Permobil will continue to monitor and if any new information is received, 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
Reports having broken one of his fingers after having driven his device into a door frame while attempting to enter his apartment.Report indicates the end-user having sustained a broken finger because of the impact.
Additional Manufacturer Narrative
Permobil is unable to confirm a device malfunction occurred as alleged due to the device not being made available, by the end-user, for inspection/evaluation.Numerous attempts have been made in attempt to evaluate the device, but with each scheduled attempt the appointment was cancelled by the end-user.As the device is not being made available, permobil cannot reach a determination as to possible root cause of the rpeorted event without speculation.Permobil will continue to monitor and if any new information is provided, the case investigation will be re-opened and a follow-up report submitted.

• 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: 12842872
• Report Number: 1221084-2021-00039
• Device Sequence Number: 11835311
• Product Code: ITI
• UDI-Device Identifier: 17330818345674
• UDI-Public: 17330818345674
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K123290
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Consumer
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 01/25/2022

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?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/27/2021
• Supplement Date Received by Manufacturer: 10/27/2021
• Initial Report FDA Received Date: 11/19/2021
• Supplement Report FDA Received Date: 01/25/2022
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 05/04/2020
• 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: Other
• Patient Sex: Male