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

Device Problem Insufficient Information (3190)

Patient Problems Skin Tears (2516); Partial thickness (Second Degree) Burn (2694)

Event Date 12/28/2015

Event Type  malfunction  

Event Description

Patient developed blisters and skin tears on thighs and flank.

• Brand Name: ARCTIC SUN PADS
• Type of Device: SYSTEM, THERMAL REGULATING
• Manufacturer (Section D): C.R. BARD MEDICAL; 8195 industrial blvd.; covington GA 30014
• MDR Report Key: 6088882
• MDR Text Key: 59467832
• Report Number: 6088882
• Device Sequence Number: 1
• Product Code: DWJ
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• 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 Received: 11/09/2016
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 09/30/2016
• Event Location: Hospital
• Date Report to Manufacturer: 09/30/2016
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 86 YR