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

Model Number	0015811
Medical Device Problem Code	Unintended Movement (3026)
Health Effect - Clinical Code	Abrasion (1689)
Date of Event	02/18/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported while unloading a patient from the ambulance the safety bail was released prior to the head end legs being lowered and the stretcher lowered from the ambulance.The incident report alleged patient injuries in the nature of a laceration to the head and a shoulder injury.Both injuries requiring medical intervention.It was further alleged one of the medics sustained a blister as a result of the incident requiring first aid at the emergency room (er).
Event or Problem Description
It was reported while unloading a patient from the ambulance the safety bail was released prior to the head end legs being lowered and the stretcher lowered from the ambulance.The incident report alleged patient injuries in the nature of a laceration to the head and a shoulder injury.Both injuries requiring medical intervention.It was further alleged one of the medics sustained a blister as a result of the incident requiring first aid at the er.
Additional Manufacturer Narrative
The customer commissioned their own evaluation of the stretcher.They confirmed the stretcher had never been removed from service following the reported incident, was evaluated and continues to be in service.Details of the evaluation were not provided; however, there have been no allegations of a product malfunction being the contributor to the incident.No additional details have been provided regarding the alleged injuries.

• Brand Name: INX FOR INLINE
• Common Device Name: INX FOR INLINE
• 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
• MDR Report Key: 16471620
• Report Number: 1523574-2023-00003
• Device Sequence Number: 15387993
• Product Code: FPO
• UDI-Device Identifier: 00190790001339
• UDI-Public: 00190790001339
• Combination Product (Y/N): N
• Initial Reporter State: IL
• 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): 04/18/2023

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: 0015811
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 02/24/2023
• Supplement Date Received by Manufacturer: 02/24/2023
• Initial Report FDA Received Date: 03/02/2023
• Supplement Report FDA Received Date: 04/18/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 11/19/2018
• 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: Female
• Patient Weight: 57 KG