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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: C.R. BARD MEDICAL ARCTIC SUN PADS SYSTEM, THERMAL REGULATING

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C.R. BARD MEDICAL ARCTIC SUN PADS SYSTEM, THERMAL REGULATING Back to Search Results
Device Problem Difficult to Remove (1528)
Patient Problems Rash (2033); Skin Inflammation (2443)
Event Date 11/06/2015
Event Type  malfunction  
Event Description
There was great difficulty removing the pads from the patient. The adhesive was like glue; patient had redness and rash on back and legs.
 
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Brand NameARCTIC SUN PADS
Type of DeviceSYSTEM, THERMAL REGULATING
Manufacturer (Section D)
C.R. BARD MEDICAL
8195 industrial blvd.
covington GA 30014
MDR Report Key6088923
MDR Text Key59479725
Report Number6088923
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 User Facility
Reporter Occupation Risk Manager
Type of Report Initial
Report Date 09/30/2016
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received11/09/2016
Is this a Product Problem Report? Yes
Device Operator
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Was the Report Sent to FDA? Yes
Date Report Sent to FDA09/30/2016
Event Location Hospital
Date Report to Manufacturer09/30/2016
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: 11/09/2016 Patient Sequence Number: 1
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