MAUDE Adverse Event Report: 3M COMPANY, 3M HEALTHCARE BAIR PAW WARMING GOWN; SYSTEM THERMAL REGULATING

Model Number 81003

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Erythema (1840); Skin Discoloration (2074)

Event Date 05/16/2019

Event Type  Injury  

Event Description

Patient was in the operating room for procedure with the bair paw warming gown on.The arms extended to the sides and warmer was completely inflated without any obstructions.Temp on high and flow on low watt.The physician evaluated the patient and noted chest and both arms were discolored, and her face was flushed.The warmer was discontinued at that time.Fda safety report id # (b)(4).

• Brand Name: BAIR PAW WARMING GOWN
• Type of Device: SYSTEM THERMAL REGULATING
• Manufacturer (Section D): 3M COMPANY, 3M HEALTHCARE
• MDR Report Key: 8658724
• MDR Text Key: 146833846
• Report Number: MW5087051
• Device Sequence Number: 1
• Product Code: DWJ
• Combination Product (y/n): N
• 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: 05/28/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 81003
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 05/30/2019
• Was Device Evaluated by Manufacturer?: No Information
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 36 YR