MAUDE Adverse Event Report: MOLNLYCKE HEALTHCARE BARRIER EASYWARM

Catalog Number 30475

Device Problem Improper or Incorrect Procedure or Method (2017)

Patient Problem Partial thickness (Second Degree) Burn (2694)

Event Date 10/08/2014

Event Type  Injury  

Event Description

(b)(4).Received notification that a pt got a second degree burn on his right heel (5 cm) after wrong use of the active self warming blanket.The pt was anesthetized for hip replacement surgery.The burn was discovered after surgery, directly after removal of the product.The incident did prolong the pt's hospital stay, but it is unk how long.

• Brand Name: BARRIER EASYWARM
• Manufacturer (Section D): MOLNLYCKE HEALTHCARE; norcross GA
• Manufacturer Contact: jamie bradshaw ; 5550 peachtree parkway; suite 500; norcross, GA 30092 ; 4703750051
• MDR Report Key: 4223494
• MDR Text Key: 5064499
• Report Number: 3004763499-2014-00017
• Device Sequence Number: 1
• Product Code: KGO
• Combination Product (y/n): N
• PMA/PMN Number: K132048
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility
• Reporter Occupation: Not Applicable
• Type of Report: Initial
• Report Date: 10/27/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/29/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 30475
• Device Lot Number: 14 B012
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/10/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 21 YR