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 Problems Erythema (1840); Rash (2033)

Event Date 07/26/2019

Event Type  malfunction  

Event Description

Post procedure, the bair paw warming gown was removed from the pt and they were noted to have red rash to bilateral upper arms and on their chest.The redness was only present where the warming gown came in contact with the pt.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: 9244567
• MDR Text Key: 164122729
• Report Number: MW5090672
• 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

• 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
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 10/25/2019
• 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: 69 YR