MAUDE Adverse Event Report: FERNO-WASHINGTON, INC. INX FOR INLINE

Model Number	0015803
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/29/2025
Type of Reportable Event	Malfunction
Event or Problem Description
The end user returned their stretcher for service and repair and one of the transport wheels was found to be detached from the stretcher.No additional information has been provided as to how the wheel became detached or if an adverse event was associated.
Additional Manufacturer Narrative
The subject stretcher was returned to manufacturer for visual and functional evaluation.The reported issue was confirmed; however, additional information was not provided as to how and/or when the wheel became detached from the stretcher.There have been no allegations of the reported issue being associated with an adverse event or injury.The stretcher was repaired by installing a new wheel assembly and then returned to the customer.The stretcher has been in the field since june 2020.
Event or Problem Description
The end user returned their stretcher for service and repair and one of the transport wheels was found to be detached from the stretcher.No additional information has been provided as to how the wheel became detached or if an adverse event was associated.

• Brand Name: INX FOR INLINE
• Common Device Name: INX FOR INLINE
• Manufacturer (Section D): FERNO-WASHINGTON, INC.; 70 wiel way; wilmington OH 45177
• Manufacturer (Section G): FERNO-WASHINGTON, INC.; 70 wiel way; wilmington OH 45177
• Manufacturer Contact: dawn greene ; 70 wiel way; wilmington, OH 45177 ; 9372832900
• MDR Report Key: 24159329
• Report Number: 1523574-2026-00010
• Device Sequence Number: 9112248
• Product Code: FPO
• UDI-Device Identifier: 00190790000004
• UDI-Public: (01)00190790000004(11)200629
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Other
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 01/28/2026

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: 0015803
• Device Catalogue Number: 0015803
• Device Lot Number: M743940
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/29/2025
• Supplement Date Received by Manufacturer: 12/29/2025
• Initial Report FDA Received Date: 01/23/2026
• Supplement Report FDA Received Date: 01/28/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/29/2020
• 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: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown