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

Catalog Number UNKNOWN

Device Problem Insufficient Information (3190)

Patient Problems Bruise/Contusion (1754); Death (1802); Tissue Damage (2104); Coma (2417); Low Oxygen Saturation (2477); 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 was on the end of life pathway and developed some marks on his legs where the arctic sun pads had been placed.His skin was incredibly friable, tissue paper like, bruised, oedematous.It is documented that this patient was peripherally shut down/ cool, not on inotropes and blood pressure was within normal range.Patient has been in the icu for four days.During this time he has required the use of the arctic sun.During the evening the patient deteriorated.The oxygen level fell, pulmonary oedema was present and the peripheries shut down.The patient's skin is very thin.When removing the sticky pads of the arctic sun great care was taken, however, the patient incurred skin tears/ small wounds.The patient's skin peeled away from the patient's body when the pads were removed.Nothing was put on the skin after the pads were removed due to the patient was palliated and in a coma.Clarification: therapy was discontinued.Then the pads were taken off.This is when the skin tears occurred.Therapy was stopped after this because it had been ordered to be discontinued.No pictures are available.The patient died two days later.The facility stated that the patient was dying while on therapy and the skin had poor perfusion.The patient's reported death was an incidental element of the patient's medical history and is unrelated to the event.There is no indication, report or allegation that the device malfunction was related to the death of the patient.

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).

• Brand Name: ARCTICGEL PADS
• Type of Device: ARCTIC 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: janna parks ; 8195 industrial blvd; covington, GA 30014 ; 7707846100
• MDR Report Key: 5513001
• MDR Text Key: 40780566
• Report Number: 1018233-2016-00295
• Device Sequence Number: 1
• Product Code: DWJ
• Combination Product (y/n): N
• Reporter Country Code: UK
• PMA/PMN Number: K002577
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,other
• Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date: 03/19/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/20/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/19/2016
• 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 Sequence Number: 1