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

Model Number	0015790
Medical Device Problem Code	Unintended Movement (3026)
Health Effect - Clinical Code	Limb Pain (4836)
Date of Event	04/26/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported while unloading a patient from the ambulance, the stretcher allegedly did not catch the safety hook and the stretcher tilted to the side.It was alleged the patient sustained injury described as "right elbow pain/injury".Medical intervention sought was an xray.No additional information was provided on the alleged injury or the outcome of the medical intervention.
Additional Manufacturer Narrative
The stretcher was not made available to the manufacturer for evaluation; however, the end user advised they had their service company evaluate the stretcher and it is operating according to specification and has been returned to service.
Event or Problem Description
It was reported while unloading a patient from the ambulance, the stretcher allegedly did not catch the safety hook and the stretcher tilted to the side.It was alleged the patient sustained injury described as "right elbow pain/injury".Medical intervention sought was an xray.No additional information was provided on the alleged injury or the outcome of the medical intervention.

• Brand Name: 35 XST PROFLEXX
• Common Device Name: 35 XST PROFLEXX
• Manufacturer (Section D): FERNO-WASHINGTON, INC.; 70 weil way; wilmlngton OH 45177
• Manufacturer (Section G): FERNO-WASHINGTON, INC.; 70 weil way; wilmlngton OH 45177
• Manufacturer Contact: dawn greene ; 70 weil way; wilmlngton, OH 45177 ; 9372832900
• MDR Report Key: 16911310
• Report Number: 1523574-2023-00012
• Device Sequence Number: 6148315
• Product Code: FPO
• UDI-Device Identifier: 00190790000585
• UDI-Public: (01)00190790000585(11)180326
• Combination Product (Y/N): N
• Initial Reporter State: TX
• 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): 07/28/2023

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: 0015790
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 04/27/2023
• Supplement Date Received by Manufacturer: 04/27/2023
• Initial Report FDA Received Date: 05/11/2023
• Supplement Report FDA Received Date: 07/28/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 03/26/2018
• 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: Male
• Patient Weight: 95 KG