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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BD / C. R. BARD, INC. ARTIC SUN TEMPERATURE MANAGEMENT SYSTEM SYSTEM, THERMAL REGULATING

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BD / C. R. BARD, INC. ARTIC SUN TEMPERATURE MANAGEMENT SYSTEM SYSTEM, THERMAL REGULATING Back to Search Results
Model Number 5000
Device Problem Temperature Problem (3022)
Patient Problem Full thickness (Third Degree) Burn (2696)
Event Date 01/26/2022
Event Type  Injury  
Event Description
Pt admitted with left mca stroke. Placed on artic sun for refractory temperature. The temp remained around 5 degrees celsius. When the pads were removed in the morning. The pt was noted to have 1st degree burns that progressed to full thickness burns.
 
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Brand NameARTIC SUN TEMPERATURE MANAGEMENT SYSTEM
Type of DeviceSYSTEM, THERMAL REGULATING
Manufacturer (Section D)
BD / C. R. BARD, INC.
MDR Report Key13975450
MDR Text Key288362399
Report NumberMW5108673
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 Risk Manager
Type of Report Initial
Report Date 03/25/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received04/01/2022
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date05/31/2022
Device Model Number5000
Was Device Available for Evaluation? No Answer Provided
Is the Reporter a Health Professional? Yes
Is This a Reprocessed and Reused Single-Use Device? No

Patient Treatment Data
Date Received: 04/01/2022 Patient Sequence Number: 1
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