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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 SUN GEL PADS

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PRODUCTOS PARA EL CUIDADO DE LA SALUD -9611590 ARCTIC SUN GEL PADS Back to Search Results
Catalog Number 317-09-02
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Erythema (1840); Tissue Breakdown (2681)
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 a patient with a spinal injury was being treated with the normothermia program on the arctic sun. The patient allegedly had broken skin under the gel pads. During examination of the patient's skin, two lines of erythema were found parallel to the spine (either side of the spine). The lines were approximately 40cm in length. There was a very small broken area of skin approximately 1. 5cm in length and 1mm in width. The arctic sun had been on the patient for 90 hours. He was being nursed on a special spinal injury pressure relieving bed. The patient was being turned every two hours on a special spinal bed that repositions. Skin checks were performed every 3 hours. There was not any medication or medical intervention done to the areas of question. Therapy was continued after noticing the marked skin; however, it was later discontinued (not due to the skin issues).
 
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 with a spinal injury was being treated with normothermia therapy on the arctic sun. The patient allegedly had broken skin under the gel pads. During examination of the patient's skin, two lines of erythema were found parallel to the spine (either side of the spine). The lines were approximately 40cm in length. There was a very small broken area of skin approximately 1. 5cm in length and 1mm in width. The arctic sun had been on the patient for 90 hours. He was being nursed on a special spinal injury pressure relieving bed. The patient was being turned every two hours on a special spinal bed that repositions. Skin checks were performed every 3 hours. No medication or medical intervention was reported. Therapy was continued after noticing the marked skin; however, it was later discontinued for reasons unrelated to the skin issue.
 
Manufacturer Narrative
Received 1 used arcticgel pad kit without original packaging. During the visual evaluation of the returned kit of pads, it was noted what appeared to be skin which still adhered to the pads. No manufacturing deficiencies were noted on all four pads and no damages were noted as well. The reported event was confirmed with unknown cause. The device history record was reviewed and found nothing that could have caused or contributed to the reported event. 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.
 
Event Description
It was reported that a patient with a spinal injury was being treated with normothermia therapy on the arctic sun. The patient allegedly had broken skin under the gel pads. During examination of the patient's skin, two lines of erythema were found parallel to the spine (either side of the spine). The lines were approximately 40cm in length. There was a very small broken area of skin approximately 1. 5cm in length and 1mm in width. The arctic sun had been on the patient for 90 hours. He was being nursed on a special spinal injury pressure relieving bed. The patient was being turned every two hours on a special spinal bed that repositions. Skin checks were performed every 3 hours. No medication or medical intervention was reported. Therapy was continued after noticing the marked skin; however, it was later discontinued for reasons unrelated to the skin issue.
 
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Brand NameARCTIC SUN 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 Key6069236
MDR Text Key58844166
Report Number1018233-2016-01513
Device Sequence Number1
Product Code DWJ
Combination Product (y/n)N
Reporter Country CodeUK
PMA/PMN Number
K142702
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type consumer,other
Reporter Occupation
Type of Report Initial,Followup,Followup
Report Date 11/17/2016
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received11/01/2016
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Expiration Date06/30/2017
Device Catalogue Number317-09-02
Device Lot NumberNGAT1460
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer10/27/2016
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received11/17/2016
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured08/12/2016
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: 11/01/2016 Patient Sequence Number: 1
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