• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MEDIVANCE, INC. ARCTIC SUN 5000 SYSTEM, THERMAL REGULATING

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

MEDIVANCE, INC. ARCTIC SUN 5000 SYSTEM, THERMAL REGULATING Back to Search Results
Model Number 50000000
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Partial thickness (Second Degree) Burn (2694); Full thickness (Third Degree) Burn (2696)
Event Date 04/14/2020
Event Type  Injury  
Event Description
Patient noted to have back and thigh wounds with a mixture of superficial and deep partial thickness, and an area of full thickness burn to the left lower back, secondary to use of arctic sun warranting transfer to a burn unit.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand NameARCTIC SUN 5000
Type of DeviceSYSTEM, THERMAL REGULATING
Manufacturer (Section D)
MEDIVANCE, INC.
321 south taylor avenue suite 200
louisville CO 80027
MDR Report Key10733049
MDR Text Key213002677
Report Number10733049
Device Sequence Number1
Product Code DWJ
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source User Facility
Reporter Occupation Other Health Care Professional
Type of Report Initial,Followup
Report Date 10/16/2020,06/01/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received10/26/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Model Number50000000
Device Catalogue Number50000000
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer06/02/2020
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? Yes
Date Report Sent to FDA10/16/2020
Device Age6 MO
Event Location Hospital
Date Report to Manufacturer10/26/2020
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 Unkown

Patient Treatment Data
Date Received: 10/26/2020 Patient Sequence Number: 1
-
-