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

Model Number	TILITE Z
Medical Device Problem Codes	Mechanical Problem (1384); Detachment of Device or Device Component (2907)
Health Effect - Clinical Codes	Abrasion (1689); Bone Fracture(s) (1870)
Date of Event	12/16/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Reports indicate the solid tire having become detached from the wheelchair rim while device was at speed.This reportedly kept the end-user from slowing the wheelchair due to no tire being on the chair to brake with, forcing the end-user to evacuate the wheelchair seating to the ground to avoid collision.Reports claim when they evacuated, the fall resulted in abrasions and a fracture to a finger on their right hand.The report claims the solid tire remained intact and had no signs of breakage, only that it came off of the rim.At time of report, permobil has not been able to evaluate the device, thus unable to reach a determination as to possible root cause.If any new information is received, a follow-up report will be submitted.
Event or Problem Description
Received report claiming while maneuvering the manual wheelchair on a downhill grade on a neighborhood street, reports the solid tire of the right wheel became detached from the rim.This reportedly caused the end-user the inability to stop the forward momentum and forced the end-user to jump out of the seating in order to avoid a collision with an immovable object.Report indicates when the end-user chose to evacuate the seating to the ground, they sustained 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: 24045159
• Report Number: 3032618-2026-00001
• Device Sequence Number: 21100943
• Product Code: IOR
• UDI-Device Identifier: 00853316008136
• UDI-Public: (01)00853316008136(11)250619
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K990358
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Y
• Reporter Type: Manufacturer
• Report Source: Consumer
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 01/12/2026

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: TILITE Z
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/16/2026
• Initial Report FDA Received Date: 01/12/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 06/19/2025
• 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