MAUDE Adverse Event Report: AUGUSTINE TEMPERATURE MANAGEMENT, LLC HOT DOG WARMING BLANKET; SYSTEM, THERMAL REGULATING

Device Problem Overheating of Device (1437)

Patient Problem Burn, Thermal (2530)

Event Date 12/27/2019

Event Type  Injury  

Event Description

During a routine dental cleaning, the blanket malfunctioned and the blanket overheated.The dog was severely burned.The dog was placed on oral and topicals antibiotics.The dog was taken to the veterinary hosp to undergo anesthetized dental cleaning and vaccinations on (b)(6) 2019.The outcome of the procedure was excellent.On (b)(6) 2019, the owner noticed a lump on the left side of the dog's neck.The owner assumed the lump was associated with vaccination injection.On (b)(6) 2020, the owner noticed the lump was larger, with a black center.The owner brought the dog back to the hosp on (b)(6) 2020 where the veterinarian suspected a burn.The fur was shaved and it revealed two burn marks.The veterinarian mentioned to the owner that two other dogs were burned from the use of the hot dog warming blanket.

• Brand Name: HOT DOG WARMING BLANKET
• Type of Device: SYSTEM, THERMAL REGULATING
• Manufacturer (Section D): AUGUSTINE TEMPERATURE MANAGEMENT, LLC ; 6581 city west pkwy; eden prairie MN 55344
• MDR Report Key: 9627215
• MDR Text Key: 176394411
• Report Number: MW5092474
• Device Sequence Number: 1
• Product Code: DWJ
• Combination Product (y/n): Y
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Patient Family Member or Friend
• Type of Report: Initial
• Report Date: 01/22/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/23/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Patient Sequence Number: 1