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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 ARCTIC SUN GEL PADS

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PRODUCTOS PARA EL CUIDADO DE LA SALUD -9611590 ARCTIC GEL PADS ARCTIC SUN GEL PADS Back to Search Results
Catalog Number 317-07
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Hemorrhage/Bleeding (1888); Renal Failure (2041); Septic Shock (2068); Ulceration (2116)
Event Date 03/08/2017
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 that wounds were found on the patients back and thigh. The wounds were described as ulcerated. The patient was allegedly experiencing septic shock, kidney failure, and gastrointestinal bleeding. ; and was also on vasopressors. The pads were removed and replaced with a thermal blanket. It was later reported that the wounds were phlyctena, and purple in color. The wounds were on the back and measured 35 x 1. 5. The wounds were nursed with antiseptic. The patient received arctic sun therapy for 4 days, and the target temperature was 37°c. Subsequently, the pads were replaced with a thermal blanket.
 
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 states the following: ¿the instructions for use baw28-300130-00 establish the following cautioned: ¿ 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. ¿ do not allow urine, antibacterial solutions or other agents to pool underneath the arcticgel¿ pads. Urine and antibacterial agents can absorb into the pad hydrogel and cause chemical injury and loss of pad adhesion. Replace pads immediately if these fluids come into contact with the hydrogel. ¿ do not place arcticgel¿ pads directly over an electrosurgical grounding pad. The combination of heat sources may result in skin burns. ¿ carefully remove arcticgel¿ pads from the patient¿s skin at the completion of use. Aggressive removal or removal of cold pads from the patient¿s skin may result in skin tears. ¿use pads immediately after opening. Do not store pads in opened pouch. ¿ if warranted, use pressure relieving or pressure reducing devices under the patient to protect from skin injury. ¿ the water content of the hydrogel affects the pad¿s adhesion to the skin and conductivity, and therefore, the efficiency of controlling patient temperature. ¿ periodically check that pads remain moist and adherent. Replace pads when the hydrogel no longer uniformly adheres to the skin. Replacing pads at least every 5 days is recommended. ¿ (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 wounds were found on the patients back and thigh. The wounds were described as ulcerated. The patient was allegedly experiencing septic shock, kidney failure, and gastrointestinal bleeding. ; and was also on vasopressors. The pads were removed and replaced with a thermal blanket. It was later reported that the wounds were phlyctena, and purple in color. The wounds were on the back and measured 35 x 1. 5. The wounds were nursed with antiseptic. The patient received arctic sun therapy for 4 days, and the target temperature was 37°c. Subsequently, the pads were replaced with a thermal blanket.
 
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Brand NameARCTIC GEL 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
amy gravley
8195 industrial blvd
covington, GA 30014
7707846100
MDR Report Key6483020
MDR Text Key72475357
Report Number1018233-2017-01685
Device Sequence Number1
Product Code DWJ
Combination Product (y/n)N
Reporter Country CodeES
PMA/PMN Number
K142702
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 05/05/2017
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received04/11/2017
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Catalogue Number317-07
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 Received04/20/2017
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: 04/11/2017 Patient Sequence Number: 1
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