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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
Device Problem Device Operates Differently Than Expected (2913)
Patient Problems Erythema (1840); Swelling (2091); Skin Tears (2516); Fluid Discharge (2686)
Event Type  Injury  
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. The device was not returned.
 
Event Description
It was reported by the nurse that during therapy, the patient allegedly experienced skin tears as a result of the pads. It was later reported, that during the re-warm phase of therapy, superficial skin tears were found on the inner thigh, along the edges of the pad. The areas with broken skin were red/pinkish in color and leaking fluid; however, therapy was continued after the skin tears were discovered. No medical intervention was reported; however, skin checks were performed every four hours. It was noted that the patient had blisters on the abdomen and other areas of the body before arctic sun treatment began. The patient was very swollen and on vasopressors.
 
Manufacturer Narrative
The device was not returned for evaluation. 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. The device was not returned.
 
Event Description
It was reported by the nurse that during therapy, the patient allegedly experienced skin tears as a result of the pads. It was later reported, that during the re-warm phase of therapy, superficial skin tears were found on the inner thigh, along the edges of the pad. The areas with broken skin were red/pinkish in color and leaking fluid; however, therapy was continued after the skin tears were discovered. No medical intervention was reported; however, skin checks were performed every four hours. It was noted that the patient had blisters on the abdomen and other areas of the body before arctic sun treatment began. The patient was very swollen and on vasopressors.
 
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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
amy gravley
8195 industrial blvd
covington, GA 30014
7707846100
MDR Report Key6309323
MDR Text Key66761119
Report Number1018233-2017-00344
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
Reporter Occupation
Type of Report Initial,Followup
Report Date 02/08/2017
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received02/07/2017
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
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 Received02/08/2017
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: 02/07/2017 Patient Sequence Number: 1
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