• 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. ¿ 1725056 ARCTIC SUN® TEMPERATURE MANAGEMENT SYSTEM, ARCTICGEL¿ PADS NEONATAL ARCTICGEL PAD

  • 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. ¿ 1725056 ARCTIC SUN® TEMPERATURE MANAGEMENT SYSTEM, ARCTICGEL¿ PADS NEONATAL ARCTICGEL PAD Back to Search Results
Catalog Number 318-02
Device Problem Biocompatibility (2886)
Patient Problems Rash (2033); Pressure Sores (2326); Skin Inflammation/ Irritation (4545)
Event Date 09/10/2021
Event Type  Injury  
Manufacturer Narrative
The investigation is still in progress. Once the investigation is complete a supplemental report will be filed.
 
Event Description
It was reported that the nurse wanted to know whether they could place a pillowcase over the neonatal pad and stated that the neonate had some skin irritation or thermal injury. The nurse confirmed that a thin pillowcase or blanket might be used over the pad however depending on the location and extent of skin injury they might need to remove the pad. The skin injury might occur as a cumulative result of pressure time and temperature. The nurse did not place the neonatal arctic gel pad on the skin which experienced signs of ulcerations burns hives or rash. Ms and s called back and transferred to nurse for further information. The nurse reported that the neonate cooled very rapidly (less than 1 hour) from 36. 7 c to 33. 5 c and the water was cold. The pad was loosely tacked around the neonate and the patient temperature was 33. 5 c the water temperature was 29 to 32 c the flow rate was 1 lpm. The nurse stated that the affected areas are at the right and left top forearms. The skin was red and some areas were darkened but the water temperature was higher some redness was resolved. The left forearm was worse than the right and there was some peeling skin. The back head and buttocks were not affected. The nurse had padded the areas and taken the photos. The nurse stated that it could not send the photos due to health insurance portability and accountability act (hippa).
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand NameARCTIC SUN® TEMPERATURE MANAGEMENT SYSTEM, ARCTICGEL¿ PADS
Type of DeviceNEONATAL ARCTICGEL PAD
Manufacturer (Section D)
MEDIVANCE, INC. ¿ 1725056
321 s taylor ave
suite 200
louisville 80027
Manufacturer (Section G)
MEDIVANCE, INC. ¿ 1725056
321 s taylor ave
suite 200
louisville 80027
Manufacturer Contact
yonic anderson
8195 industrial blvd
covington 30014
7707846100
MDR Report Key12569417
MDR Text Key274531300
Report Number1018233-2021-06162
Device Sequence Number1
Product Code DWJ
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K142702
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Other,Health Professional,User Facility
Reporter Occupation
Type of Report Initial,Followup
Report Date 11/11/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received10/04/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Catalogue Number318-02
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Date Manufacturer Received11/11/2021
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

Patient Treatment Data
Date Received: 10/04/2021 Patient Sequence Number: 1
-
-