MAUDE Adverse Event Report: FERNO-WASHINGTON, INC. 35-XST PROFLEXX-ST ELECTRC BLU

Model Number	0015791
Medical Device Problem Code	Appropriate Device Problem Term/Code Not Available (3191)
Health Effect - Clinical Code	Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581)
Date of Event	02/06/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
The customer reported the device was involved in a motor vehicle accident while transporting a patient.The stretcher was reported as to having remained locked in the fastening system throughout; however, the patient is alleging a neck injury, as a result of the accident.No further details have been provided.

• Brand Name: 35-XST PROFLEXX-ST ELECTRC BLU
• Common Device Name: 35-XST PROFLEXX-ST ELECTRC BLU
• Manufacturer (Section D): FERNO-WASHINGTON, INC.; 70 weil way; wilmington OH 45177
• Manufacturer (Section G): FERNO-WASHINGTON, INC.; 70 weil way; wilmington OH 45177
• Manufacturer Contact: dawn greene ; 70 weil way; wilmington, OH 45177 ; 9372832900
• MDR Report Key: 14056654
• Report Number: 1523574-2022-00005
• Device Sequence Number: 4766308
• Product Code: FPO
• UDI-Device Identifier: 00190790000363
• UDI-Public: 00190790000363
• Combination Product (Y/N): N
• Initial Reporter State: MA
• 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
• Type of Report: Initial
• Report Date (Section B): 04/08/2022

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: 0015791
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 04/06/2022
• Initial Report FDA Received Date: 04/08/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 02/04/2019
• 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: Female