MAUDE Adverse Event Report: KIMBERLY CLARK PATIENT WARMING SYSTEM THERMAL PAD/SPLIT TORSO

Lot Number M5187P101

Device Problem Insufficient Information (3190)

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

Event Date 02/08/2016

Event Type  Injury  

Event Description

Patient had the warming device in use during coronary artery bypass surgery and sustained a second degree burn.Pt had prolonged surgery.The incident was not known during surgery and discovered in the icu and the disposable device was discarded.The warming device was used during the length of the surgery on (b)(6) 2016.The pad is disposable and the warming unit is reusable.Reason for use: warming device used for maintaining body temperature during surgery.

• Brand Name: PATIENT WARMING SYSTEM THERMAL PAD/SPLIT TORSO
• Type of Device: PATIENT WARMING SYSTEM THERMAL PAD/SPLIT TORSO
• Manufacturer (Section D): KIMBERLY CLARK; dallas TX
• MDR Report Key: 5454786
• MDR Text Key: 38864028
• Report Number: MW5060392
• Device Sequence Number: 1
• Product Code: DWJ
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 02/19/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/19/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Device Lot Number: M5187P101
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: Yes
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 68 YR
• Patient Weight: 36