MAUDE Adverse Event Report: TILITE TILITE ZRA; MANUAL WHEELCHAIR

Model Number	N/A
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Bone Fracture(s) (1870); Hip Fracture (2349)
Date of Event	07/14/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
This chair was made to specifications provided by dealer.The root cause of the end user's injury is failure on the part of the dealer to provide adequate specficiations for the end-user.Tilite has no direct contact with end user and recieves all chair specifications - not patient dimensions - from the dealer.
Event or Problem Description
End user's front wheels "hit the asphalt" and fell forward out of the chair, resulting in a broken hip and 1 month of hospitalization.

• Brand Name: TILITE ZRA
• Common Device Name: MANUAL WHEELCHAIR
• Manufacturer (Section D): TILITE; 2701 w court st; pasco WA 99301
• Manufacturer (Section G): TISPORT LLC; 2701 w court st; pasco WA 99301
• Manufacturer Contact: edgar zamarron ; 2701 w court st; pasco, WA 99301
• MDR Report Key: 23648808
• Report Number: 3032618-2025-00006
• Device Sequence Number: 11987689
• Product Code: IOR
• UDI-Device Identifier: 00853316008051
• UDI-Public: (01)00853316008051(11)231031
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K990358
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: User Facility
• Initial Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial
• Report Date (Section B): 11/25/2025

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: N/A
• 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: 11/13/2025
• Initial Report FDA Received Date: 11/25/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization
• Patient Sex: Unknown