MAUDE Adverse Event Report: PRODUCTOS PARA EL CUIDADO DE LA SALUD -9611590 ARCTICGEL PADS; ARCTIC SUN PADS

Catalog Number 317-05

Device Problem Insufficient Information (3190)

Patient Problems Cardiac Arrest (1762); Death (1802); Erythema (1840); Injury (2348); Skin Tears (2516)

Event Date 05/24/2016

Event Type  Injury  

Manufacturer Narrative

No physical sample only a picture was returned for evaluation; however, during the visual evaluation it was not possible to describe any condition of the product that would have contributed to the reported issue since the photo is about the patient.The device history record was reviewed and found nothing that could have caused or contributed to the reported event.The instructions 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.Sample discarded.

Event Description

It was reported that a set of arctic sun gel pads were placed on the patient.Part of the patient's skin became red and it was observed that skin tear had occurred.The patient had cardiac arrest prior to hospital admission.Upon admission the arctic sun gel pads were put on to the patient.The patient's skin was intact and no skin injury was observed before therapy.It was reported by the health care professional that the skin injury was present on both legs.The patient was also catheterized and on vasopressor.Upon hand over from night staff to morning staff, a skin check was noted in the patient's note.During verbal hand over the health care provider mentioned that the back of the patient was checked; however, there was no mention of the patient's legs where the skin injury was found.The pads were thrown away and not available for return.It is unknown if anything was placed on the skin.Therapy was then discontinued.The patient's odds of surviving were small.Patient was not on therapy when he passed.The nurse educator stated that "the diagnosis was out of hospital cardiac arrest with poor prognosis and the patient has since passed away, the patient was cooled initially and then rewarmed" ((b)(6) 3.33pm).Due to this statement it has been decided that the patient died due to natural causes.The patient's reported death was an incidental element of the patient's medical history and is unrelated to the reason for the complaint.There is no indication, report or allegation that the device malfunction was related to the patient's death.

• Brand Name: ARCTICGEL PADS
• Type of Device: ARCTIC SUN 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 Key: 5732536
• MDR Text Key: 47638727
• Report Number: 1018233-2016-00759
• Device Sequence Number: 1
• Product Code: DWJ
• Combination Product (y/n): N
• Reporter Country Code: AS
• PMA/PMN Number: K002577
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 05/25/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/17/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 11/30/2016
• Device Catalogue Number: 317-05
• Device Lot Number: NGZJ3244
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/25/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/19/2015
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention