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

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

Patient Problem Rash (2033)

Event Date 08/19/2019

Event Type  malfunction  

Event Description

Post procedure the anesthesiologist removed the drape noticing a rash to the skin where the bair paw warming gown was placed on the upper body.The rash was predominantly to the pt's left arm approx 4 inch area.Fda safety report id# (b)(4).

• Brand Name: BAIR PAW WARMING GOWN
• Type of Device: SYSTEM, THERMAL REGULATING
• Manufacturer (Section D): 3M COMPANY
• MDR Report Key: 9244577
• MDR Text Key: 164123129
• Report Number: MW5090673
• 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: Risk Manager
• Type of Report: Initial
• Report Date: 10/23/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/25/2019
• 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
• 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: 53 YR