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

Model Number 81003

Device Problem Patient-Device Incompatibility (2682)

Patient Problem Erythema (1840)

Event Date 06/04/2019

Event Type  Injury  

Event Description

Pt was noted to have red blotchy areas to their skin after the use of the bair paw warming gown.The areas were found on the upper chest where the warmer had been blowing on the skin.Fda safety report id# (b)(4).

• Brand Name: BAIR PAW WARMING GOWN
• Type of Device: SYSTEM, THERMAL REGULATING
• Manufacturer (Section D): 3M COMPANY / 3M HEALTH CARE
• MDR Report Key: 8683044
• MDR Text Key: 147508086
• Report Number: MW5087203
• 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: 06/05/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/07/2019
• 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
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 58 YR