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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: AUGUSTINE TEMPERATURE MANAGEMENT, LLC HOTDOG PATIENT WARMING BLANKET SYSTEM, THERMAL REGULATING

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AUGUSTINE TEMPERATURE MANAGEMENT, LLC HOTDOG PATIENT WARMING BLANKET SYSTEM, THERMAL REGULATING Back to Search Results
Model Number B105
Device Problem Melted (1385)
Patient Problem Insufficient Information (4580)
Event Date 12/01/2021
Event Type  Injury  
Event Description
It was observed that a reusable patient warming blanket had multiple areas where the exterior cover had melted. Fda safety report id #(b)(4).
 
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Brand NameHOTDOG PATIENT WARMING BLANKET
Type of DeviceSYSTEM, THERMAL REGULATING
Manufacturer (Section D)
AUGUSTINE TEMPERATURE MANAGEMENT, LLC
MDR Report Key13019759
MDR Text Key282420972
Report NumberMW5106110
Device Sequence Number1
Product Code DWJ
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Voluntary
Reporter Occupation Other Health Care Professional
Type of Report Initial
Report Date 12/14/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/15/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberB105
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? Yes
Is This a Reprocessed and Reused Single-Use Device? No

Patient Treatment Data
Date Received: 12/15/2021 Patient Sequence Number: 1
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