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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: PRODUCTOS PARA EL CUIDADO DE LA SALUD -9611590 ARCTICGEL PADS ARCTIC SUN GEL PADS

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PRODUCTOS PARA EL CUIDADO DE LA SALUD -9611590 ARCTICGEL PADS ARCTIC SUN GEL PADS Back to Search Results
Catalog Number 317-09
Device Problem Insufficient Information (3190)
Patient Problems Injury (2348); Alteration In Body Temperature (2682)
Event Date 05/05/2016
Event Type  Injury  
Manufacturer Narrative
No sample was returned for evaluation. The lot number is unknown, therefore the device history record could not be reviewed. The instruction for use states the following: "do not place arcticgel pads on skin that has signs of ulcerations, burns, hives or rash. While there are no known allergies to hydrogel materials, caution should be exercised with any patient with a history of skin allergies or sensitivities. Due to underlying medical or physiological conditions, some patients are more susceptible to skin damage from pressure and heat or cold. Patients at risk include those with poor tissue perfusion or poor skin integrity due to diabetes, peripheral vascular disease, poor nutritional status or steroid or high dose vasopressor therapy. If accessible, examine the patient¿s skin under the arcticgel pads often; especially those patients at higher risk of skin injury. Skin injury may occur as a cumulative result of pressure, time and temperature. Do not place bean bags or other firm positioning devices under the arcticgel pads. Do not place any positioning devices under the pad manifolds or patient lines. ¿ (b)(4). The information provided by bard represents all of the known information at this time. Despite good faith efforts to obtain additional information, the complainant / reporter was unable or unwilling to provide any further patient, product, or procedural details to bard.
 
Event Description
It was reported that the patient was placed on the arctic sun device on (b)(6) 2016 post cardiac arrest. The patient received cpr and was down for 45 minutes during arrest. The therapy was discontinued per end of treatment on (b)(6) 2016 at 0100. The pads were not changed at anytime. Upon removing the pads the nurse found a 4' x 1/16th in horizontal abrasion along the upper edge of both chest pads on sides of the patient, also a small blister at lower edge of pad area on left lower quadrant of the patients abdomen. It is stated that the depth of the wound was to the epidermis level. There was not any treatment placed on the wounds due to the patient was a dnr (do not resuscitate). There was not any drainage from the wounds. The patient received levophed in a moderate dose. Facility stated that routine skin checks were done and some edema was present.
 
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Brand NameARCTICGEL PADS
Type of DeviceARCTIC SUN GEL PADS
Manufacturer (Section D)
PRODUCTOS PARA EL CUIDADO DE LA SALUD -9611590
km. 7 carretera internacional
nogales, sonora 85621
MX 85621
Manufacturer (Section G)
PRODUCTOS PARA EL CUIDADO DE LA SALUD -9611590
km. 7 carretera internacional
nogales, sonora 85621
MX 85621
Manufacturer Contact
janna parks
8195 industrial blvd
covington, GA 30014
7707846100
MDR Report Key5672447
MDR Text Key45759479
Report Number1018233-2016-00678
Device Sequence Number1
Product Code DWJ
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K002577
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type health professional,other
Reporter Occupation
Type of Report Initial
Report Date 05/05/2016
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received05/23/2016
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Catalogue Number317-09
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received05/05/2016
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

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