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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MEDIVANCE, INC. ¿ 1725056 ARCTICSUN GEL PADS ARCTIC GEL PAD

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MEDIVANCE, INC. ¿ 1725056 ARCTICSUN GEL PADS ARCTIC GEL PAD Back to Search Results
Catalog Number 318-02-02
Device Problem Patient-Device Incompatibility (2682)
Patient Problems Erythema (1840); Necrosis (1971)
Event Type  malfunction  
Manufacturer Narrative
The device was not returned for evaluation. A potential failure mode could be '8. 2 bio-incompatible- effect 2: reaction¿ with a potential root cause of '8. 2. 2 materials that are contacting the patient's intact skin are not biocompatible. ¿ the lot number is unknown; therefore, the device history record could not be reviewed. The instructions for use were found adequate and state the following: "the arctic sun temperature management system is a thermal regulating system, indicated for monitoring and controlling patient temperature in adult and pediatric patients of all ages. Contraindications there are no known contraindications for the use of a non-invasive thermoregulatory system. Do not place the neonatal arctic gel pad on skin that has signs of ulcerations, burns, hives or rash. Do not remove the fabric release i
=
liner of the neonatal arctic gel pad and expose the hydrogel. Do not place the neonatal arctic gel pad hydrogel on immature (non-keratinized_ skin or premature babies. While there are no known allergies to hydrogel materials, caution should be exercised with any patient with a history of skin allergies or sensitivities. ".
 
Event Description
It was reported that the infant on the arctic sun device developed fat necrosis.
 
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Brand NameARCTICSUN GEL PADS
Type of DeviceARCTIC GEL PAD
Manufacturer (Section D)
MEDIVANCE, INC. ¿ 1725056
321 s taylor ave
louisville CO 80027
Manufacturer (Section G)
C.R. BARD, INC. (COVINGTON) -1018233
8195 industrial blvd
covington GA 30014
Manufacturer Contact
yonic anderson
8195 industrial blvd
covington, GA 30014
7707846100
MDR Report Key9008529
MDR Text Key161736079
Report Number1018233-2019-05598
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 health professional,other,use
Reporter Occupation Other Health Care Professional
Type of Report Initial,Followup,Followup
Report Date 10/07/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received09/12/2019
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date10/31/2019
Device Catalogue Number318-02-02
Device Lot NumberNGCX2370
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer09/18/2019
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received10/02/2019
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured10/27/2018
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: 09/12/2019 Patient Sequence Number: 1
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