MAUDE Adverse Event Report: TELEFLEX INCORPORATED EZ-IO; INTRAOSSEOUS LINK

Device Problem Insufficient Information (3190)

Patient Problem Complaint, Ill-Defined (2331)

Event Date 01/21/2015

Event Type  Injury  

Event Description

Patient had an intraosseous line placed by ems in the right lower extremity and developed compartment syndrome.This required an emergent fasciotomy the night of admission and then a follow-up irrigation and closure of the fasciotomies.He is being followed by orthopedics.Manufacturer: please not that we do not send products to the manufacturer, but you may arrange for pick-up by calling my number below.

• Brand Name: EZ-IO
• Type of Device: INTRAOSSEOUS LINK
• Manufacturer (Section D): TELEFLEX INCORPORATED; 4350 lockhill selma rd; suite 150; shavano park TX 78249
• MDR Report Key: 4569799
• MDR Text Key: 20118403
• Report Number: MW5041080
• Device Sequence Number: 1
• Product Code: DZL
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 02/18/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/24/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 02/02/1