MAUDE Adverse Event Report: TILITE ZRA; MANUAL WHEELCHAIR

Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	Fall (1848)
Date of Event	07/13/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Customer description indicates that the component failure occured at the wheel axle.Customer-provided image does not show axle in focus.Sample has been requested and if received, will be investigated and a follow-up report will be submitted.No root cause identification is possible with the information provided.
Event or Problem Description
End user reports that one of the rear wheels came off of her wheelchair.This resulted in her falling, end user's back impacted the axle pin of the wheel.End user's catheter was pulled out as a result of this fall.

• Brand Name: ZRA
• Common Device Name: MANUAL WHEELCHAIR
• Manufacturer (Section D): TILITE; 2701 w court st; pasco WA 99301
• Manufacturer (Section G): TILITE; 2701 w court st; pasco WA 99301
• Manufacturer Contact: jinay patel ; 2701 w court st; pasco, WA 99301 ; 5095862413
• MDR Report Key: 22709722
• Report Number: 3032618-2025-00004
• Device Sequence Number: 21060718
• Product Code: IOR
• UDI-Device Identifier: 00853316008051
• UDI-Public: (01)00853316008051(11)240618
• Combination Product (Y/N): N
• 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): Unknown
• Reporter Type: Manufacturer
• Report Source: Consumer
• Initial Reporter Occupation: Non-Healthcare Professional
• Remedial Action: Replace
• Type of Report: Initial
• Report Date (Section B): 08/04/2025

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
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/14/2025
• Initial Report FDA Received Date: 08/04/2025
• 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: Required Intervention
• Patient Sex: Unknown