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

Model Number	0015811
Medical Device Problem Code	Use of Device Problem (1670)
Health Effect - Clinical Code	Unspecified Tissue Injury (4559)
Date of Event	05/25/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported while loading the stretcher into the ambulance via manual mode, due to a dead battery, one of the medic's got their hand caught between the stretcher frame and legs resulting in a soft tissue injury.The medic sought medical treatment and required time off work; however, followup details of the injury were not provided.This incident occurred in canada.There was no report of injury or adverse effect on the patient.The end user further advised their internal investigation resulted in a finding of unintended use error.An authorized service technician did evaluate the stretcher and battery and both were found to be functioning as intended and no repairs were required.

• 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: 22438957
• Report Number: 1523574-2025-00066
• Device Sequence Number: 14241098
• Product Code: FPO
• UDI-Device Identifier: 00190790001339
• UDI-Public: (01)00190790001339(11)200608
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 07/08/2025

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: Health Professional
• Device Model Number: 0015811
• Device Catalogue Number: 0015811
• Device Lot Number: M707100
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/10/2025
• Initial Report FDA Received Date: 07/08/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/08/2020
• 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
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown