MAUDE Adverse Event Report: FERNO-WASHINGTON, INC. IN/X FOR IN/LINE

Device Problem Device Handling Problem (3265)

Patient Problem Injury (2348)

Event Date 10/26/2016

Event Type  Injury  

Manufacturer Narrative

There were no allegations of the cot malfunctioning during use.Instruction is provided in the ifu regarding the importance of two operators maintaining control of the cot at all times.No allegation of malfunction.

Event Description

It was reported while pulling the cot across a grassy area, the cot was pulled toward a hole or low spot in the ground.The operator felt the cot tipping over as it was pulled toward the hole so he reached out and grabbed it quickly.The operator is alleging a right bicep tear as a result of the incident.The incident report indicates surgery was necessary; however, no additional details on the incident, injury or medical intervention have been provided.This incident occurred on (b)(6) 2016 but was not reported to the manufacturer until 3/31/2017.The serial number of the cot in question has not been provided by the complainant.There have been no allegations of the cot malfunctioning during this reported incident.

• Brand Name: IN/X FOR IN/LINE
• Type of Device: IN/X FOR IN/LINE
• 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
• MDR Report Key: 6463786
• MDR Text Key: 71881903
• Report Number: 1523574-2017-00012
• Device Sequence Number: 1
• Product Code: FPO
• 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: Emergency Medical Technician
• Type of Report: Initial
• Report Date: 04/06/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/06/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/31/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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): Other