MAUDE Adverse Event Report: FERNO-WASHINGTON, INC. 35XNM COT

Model Number	0015788
Medical Device Problem Code	Unintended Movement (3026)
Health Effect - Clinical Code	Abrasion (1689)
Date of Event	12/31/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
A product issue on the subject stretcher was reported via medsun report #(b)(4) alleging a wheel lock issue but no specific patient incident or injury was associated with the issue.Upon further investigation with the end user, it was discovered the event associated with the subject stretcher involved restraints and not a wheel lock issue.It was reported while transporting a patient on the stretcher to an mri trailer, the patient's weight shifted while traversing a threshold and the stretcher tipped over.Reported patient injury included abrasions to nose, arms, knees and toes.The patient was not restrained to the stretcher at the time of incident nor were the provided restraints installed on the stretcher at the time of incident.There was no allegation of product malfunction contributing to the incident and there has been no additional information provided on the patient's injuries.The end user conducted an internal investigation which included a corrective action to install the provided restraints onto the stretcher before placing it back in service.
Event or Problem Description
A product issue on the subject stretcher was reported via medsun report #(b)(4) alleging a wheel lock issue but no specific patient incident or injury was associated with the issue.Upon further investigation with the end user, it was discovered the event associated with the subject stretcher involved restraints and not a wheel lock issue.It was reported while transporting a patient on the stretcher to an mri trailer, the patient's weight shifted while traversing a threshold and the stretcher tipped over.Reported patient injury included abrasions to nose, arms, knees and toes.The patient was not restrained to the stretcher at the time of incident nor were the provided restraints installed on the stretcher at the time of incident.There was no allegation of product malfunction contributing to the incident and there has been no additional information provided on the patient's injuries.The end user conducted an internal investigation which included a corrective action to install the provided restraints onto the stretcher before placing it back in service.

• Brand Name: 35XNM COT
• Common Device Name: 35XNM COT
• 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: 22542838
• Report Number: 1523574-2025-00071
• Device Sequence Number: 7029620
• Product Code: FPO
• UDI-Device Identifier: 00190790000349
• UDI-Public: (01)00190790000349(11)231003
• Combination Product (Y/N): N
• Initial Reporter State: CA
• 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): 11/20/2025

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: 0015788
• Device Catalogue Number: 0015788
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/21/2025
• Supplement Date Received by Manufacturer: 05/21/2025
• Initial Report FDA Received Date: 07/18/2025
• Supplement Report FDA Received Date: 11/20/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/03/2023
• 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
• If action reported to FDA under 21 USC 360i(g), list FDA-assigned Recall Number or include a statement: 05024200000-2024-8023
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Male