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

Model Number	M3
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Abrasion (1689); Laceration(s) (1946)
Date of Event	03/02/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Report provided from the service provider indicated the end-user was at a top of stairwell and they had attempted to turn the m3 around in a narrow area.It was described that one of the rear caster wheels dropped off the edge of the stair step, which caused the w/c to lose upright stability and topple down the stairs with the end-user.End-user reported they sustained a large gash to their leg requiring stiches.Dealer nor end-user made any claims or allegations that the device malfunctioned in any way to have contributed to this event.All information provided indicates that this event was related to inadvertent use-error in not knowing the proximity of the device to the edge of the stairway.The dhr was reviewed, and the device was found to have met specification prior to distribution.
Event or Problem Description
Report received claiming as the end-user was turning their m3 power wheelchair around in hall, next to some stairs, one of the back wheels dropped off the edge and the end-user and device fell down the stairs 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: 18982322
• Report Number: 1221084-2024-00006
• Device Sequence Number: 2867776
• Product Code: ITI
• UDI-Device Identifier: 17330818345674
• UDI-Public: 17330818345674
• Combination Product (Y/N): N
• Initial Reporter State: OR
• 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): 03/26/2024

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?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/06/2024
• Initial Report FDA Received Date: 03/26/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 11/17/2020
• 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: Hospitalization
• Patient Sex: Prefer Not To Disclose