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U.S. Department of Health and Human Services

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

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AUGUSTINE TEMPERATURE MANAGEMENT, LLC HOT DOG WARMING BLANKET SYSTEM, THERMAL REGULATING Back to Search Results
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.
 
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Brand NameHOT DOG WARMING BLANKET
Type of DeviceSYSTEM, THERMAL REGULATING
Manufacturer (Section D)
AUGUSTINE TEMPERATURE MANAGEMENT, LLC
6581 city west pkwy
eden prairie MN 55344
MDR Report Key9627215
MDR Text Key176394411
Report NumberMW5092474
Device Sequence Number1
Product Code DWJ
Combination Product (y/n)Y
Reporter Country CodeUS
Number of Events Reported1
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
0 Patients were Involved in the Event:
Date FDA Received01/23/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Was Device Available for Evaluation? No Answer Provided
Is the Reporter a Health Professional? No Answer provided
Was the Report Sent to FDA?
Event Location No Information
Is This a Reprocessed and Reused Single-Use Device?

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