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U.S. Department of Health and Human Services

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

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PRODUCTOS PARA EL CUIDADO DE LA SALUD -9611590 ARCTIC GEL PADS ARCTICSUN GEL PADS Back to Search Results
Catalog Number 317-07-02
Device Problem Insufficient Information (3190)
Patient Problem Skin Erosion (2075)
Event Date 07/08/2016
Event Type  Injury  
Manufacturer Narrative
The investigation is still in progress. Once the investigation is complete a supplemental report will be filed.
 
Event Description
It was reported that during hypothermia treatment, the patient developed red pressure marks on the legs. The complainant also reported that the patient was not injured, and the marks eventually disappeared. However, a clinical review of the photo samples received noted that there was a break in the skin.
 
Manufacturer Narrative
The investigation is still in progress. Once the investigation is complete a supplemental report will be filed. 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 during hypothermia treatment, the patient developed red pressure marks on the legs. The complainant also reported that the patient was not injured, and the marks eventually disappeared. However, a clinical review of the photo samples received noted that there was a break in the skin.
 
Manufacturer Narrative
The device was not returned for evaluation. The manufacturer cannot use the photo received as a sample, as the photo is a picture of the patient's condition, and did not reveal any condition of the product that would have contributed to the reported issue. The investigators are not clinicians, and therefore are not qualified to investigate the photo. The lot number is unknown; therefore, the device history record could not be reviewed. The instructions for use state 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. Photo sample received.
 
Event Description
It was reported that during hypothermia treatment, the patient developed red pressure marks on the legs. The complainant also reported that the patient was not injured, and the marks eventually disappeared. However, a clinical review of the photo samples received noted that there was a break in the skin.
 
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Brand NameARCTIC GEL PADS
Type of DeviceARCTICSUN 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 Key5979748
MDR Text Key55708541
Report Number1018233-2016-01299
Device Sequence Number1
Product Code DWJ
Combination Product (y/n)N
PMA/PMN Number
K142702
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,health
Reporter Occupation
Type of Report Initial,Followup,Followup
Report Date 10/17/2016
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received09/27/2016
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue Number317-07-02
Was Device Available for Evaluation? No
Date Returned to Manufacturer09/15/2016
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received10/17/2016
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

Patient Treatment Data
Date Received: 09/27/2016 Patient Sequence Number: 1
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