MAUDE Adverse Event Report: MEDIVANCE, INC. ARCTIC SUN; SYSTEM, THERMAL REGULATING

Device Problem Insufficient Information (3190)

Patient Problems Bruise/Contusion (1754); Ecchymosis (1818); Pain (1994)

Event Date 02/24/2015

Event Type  No Answer Provided  

Event Description

According to the nurse (rn), the patient had been on and off of this as needed for his disease process.Has had superficial skin breakdown and fluid filled blisters on his back.The pads are removed nightly for a bath.Wound, ostomy and continence nurse (wocn) assessed the patient.She reported some bruising and a few blisters on his back and right abdomen.Most of the bruising appears superficial and just a few open areas where the vesicles sloughed.The patient reports some pain.The affected area of the leg measured 12.8 x 4.9cm; that was the only wound measured.All are described as ecchymotic with tenderness within the wound.

• Brand Name: ARCTIC SUN
• Type of Device: SYSTEM, THERMAL REGULATING
• Manufacturer (Section D): MEDIVANCE, INC.; 321 south taylor avenue; suite 200; louisville CO 80027
• MDR Report Key: 4625715
• MDR Text Key: 18036980
• Report Number: 4625715
• Device Sequence Number: 1
• Product Code: DWJ
• 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: 03/13/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: *
• Device Operator: Nurse
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 03/13/2015
• Event Location: Hospital
• Date Report to Manufacturer: 03/24/2015
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 03/13/2015
• Patient Sequence Number: 1
• Patient Age: 27 YR
• Patient Weight: 100