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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BARD ARCTIC SUN TEMPERATURE MANAGEMENT SYSTEM

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BARD ARCTIC SUN TEMPERATURE MANAGEMENT SYSTEM Back to Search Results
Model Number 5000
Device Problem Overheating of Device (1437)
Patient Problem Partial thickness (Second Degree) Burn (2694)
Event Date 12/25/2016
Event Type  Injury  
Event Description
Patient receiving ttm therapy - h20 temp in pads reached 104 degrees and remained at 104 degrees for 12 hours. Oncoming day shift rn checked patient's skin and the arctic sun pads literally tore patient's skin off each extremity upon removal of these pads. Blisters and burns noted.
 
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Brand NameARCTIC SUN
Type of DeviceTEMPERATURE MANAGEMENT SYSTEM
Manufacturer (Section D)
BARD
covington GA
MDR Report Key6217910
MDR Text Key63820244
Report NumberMW5067008
Device Sequence Number1
Product Code DWJ
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 12/29/2016
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/29/2016
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model Number5000
Device Lot Number5000-00-00
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Was Device Evaluated by Manufacturer? No Answer Provided
Is the Device Single Use? No Answer Provided
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage

Patient Treatment Data
Date Received: 12/29/2016 Patient Sequence Number: 1
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