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

Model Number 0015811

Device Problem Unintended Movement (3026)

Patient Problem Bone Fracture(s) (1870)

Event Date 05/25/2023

Event Type  Injury  

Event Description

It was reported while a medic was loading the empty stretcher back into the ambulance, the foot end of the stretcher allegedly dropped onto their foot resulting in a broken toe.The end user reported the stretcher was evaluated and it was their conclusion the incident was a result of use error.

• Brand Name: INX FOR INLINE
• Type of Device: 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: 17049665
• MDR Text Key: 316396185
• Report Number: 1523574-2023-00016
• Device Sequence Number: 1
• Product Code: FPO
• UDI-Device Identifier: 00190790001339
• UDI-Public: (01)00190790001339(11)200406
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 06/02/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/02/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 0015811
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/31/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/06/2020
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention