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); 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.

• 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): 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 Key: 9008529
• MDR Text Key: 161736079
• Report Number: 1018233-2019-05598
• 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