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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 SMALL PADS

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PRODUCTOS PARA EL CUIDADO DE LA SALUD -9611590 ARCTICGEL PADS ARCTIC SUN SMALL PADS Back to Search Results
Catalog Number 317-05
Device Problem Insufficient Information (3190)
Patient Problem Skin Tears (2516)
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.
 
Event Description
It was reported that a patient experienced two skin tears on the right thigh. The skin tears were found during a routine skin check on ((b)(6) 2016). Skin checks were done every two hours. A dressing was placed over the tears and the pad was placed back on the right thigh and therapy continued. The patient was started on the device on ((b)(6) 2016) at 0730 and treatment was stopped on ((b)(6) 2016) at 1400. The patient was receiving treatment for 4. 5 days. Water temperatures were 42-50 for the first couple of hours and 80-90 f during maintenance period. The skin tears were (0. 5 x 1 cm) in size. The depth of the tear was to the epidermis layer of skin. The patient had been admitted for sudden cardiac arrest.
 
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.
 
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Brand NameARCTICGEL PADS
Type of DeviceARCTIC SUN SMALL 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 Key5626610
MDR Text Key44273012
Report Number1018233-2016-00563
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 company representative,other
Reporter Occupation
Type of Report Initial,Followup
Report Date 05/02/2016
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received05/03/2016
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Catalogue Number317-05
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received05/02/2016
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: 05/03/2016 Patient Sequence Number: 1
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