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

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.

• Brand Name: ARCTICSUN GEL PADS
• Type of Device: ARCTIC 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 Key: 9008535
• MDR Text Key: 161736643
• Report Number: 1018233-2019-05599
• Device Sequence Number: 1
• Product Code: DWJ
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K142702
• Number of Events Reported: 1
• 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 Received: 09/12/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes

Device Operator

• Device Expiration Date: 10/31/2019
• Device Catalogue Number: 318-02-02
• Device Lot Number: NGCX2370
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/18/2019
• Is the Reporter a Health Professional?: Yes

Was the Report Sent to FDA?

• Event Location: No Information
• Date Manufacturer Received: 10/02/2019
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/27/2018
• 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