MAUDE Adverse Event Report: TISPORT, LLC TILITE X; MANUAL WHEELCHAIR

Model Number	X
Medical Device Problem Code	Use of Device Problem (1670)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	11/21/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Report indicates the dealer had performed some adjustments on the mwc to where they lowered the stf height.Reports when the client left the facility, the device was equipped with anti-tip supports.Report indicated the end-user having removed the anti-tip supports shortly after having received the chair, and when performing a wheelie, the device fell over backward causing the end-user to strike their head on the pavement.Report indicaetd the end-user was tken to the hospital, but did not provide any information as to the extent of injury, or if any medical intervention was required.No claims or allegation of any product malfunction having occurred with all indications of inadvertent use error as being the cause.
Event or Problem Description
Received report that while the end-user was attempting to lift the front end of their manual wheelchair via a wheelie, the chair reportedly flipped over backward which resulted in the end-user striking their head on the ground resulting in an injury requiring medical intervention to address.

• Brand Name: TILITE X
• Common Device Name: MANUAL WHEELCHAIR
• Manufacturer (Section D): TISPORT, LLC; 2701 w. court st.; pasco WA 99301
• Manufacturer (Section G): TISPORT LLC; 300 duke drive; lebanon TN 37090
• Manufacturer Contact: ivan fernandez ; 300 duke drive; lebanon, TN 37090 ; 8007360925
• MDR Report Key: 23750927
• Report Number: 3032618-2025-00007
• Device Sequence Number: 9583562
• Product Code: IOR
• UDI-Device Identifier: 00853316008129
• UDI-Public: (01)00853316008129(11)250601
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K072311
• 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): 12/08/2025

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: X
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/21/2025
• Initial Report FDA Received Date: 12/08/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 06/01/2025
• 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