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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); Patient Problem/Medical Problem (2688)
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: "there are no known contraindications for the use of a noninvasive 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 liner of the neonatal arctic gel pad and expose the hydrogel. While there re no known allergies to hydrogel materials, caution should be exercised with any patient with a history of ski 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)
MEDIVANCE, INC. ¿ 1725056
321 s taylor ave
louisville CO 80027
Manufacturer Contact
yonic anderson
8195 industrial blvd
covington, GA 30014
7707846100
MDR Report Key9008535
MDR Text Key161736643
Report Number1018233-2019-05599
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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