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

Device Problem Insufficient Information (3190)

Patient Problems Death (1802); Injury (2348); Alteration In Body Temperature (2682)

Event Type  Injury  

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: ¿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. The device was not returned.

Event Description

It was reported that a patient developed blisters under the arctic sun gel pads during therapy. The patient was an (b)(6) female that had completed therapy on the arctic sun device. Upon removal of the pads there were blisters that had been covered with a protective barrier and then the pads put back over the blisters. It was reported that the skin was intact prior to initiating therapy. The nurse also mentioned that she believed there was an alarm for the water being too hot for too long but could not confirm that. The patient did expire at some point after the completion of therapy. However, the patient expired due to natural causes. The nurse reported that the death was due to the patient's condition and did not allege the death against the device. It was later reported that the patient was reported to be hypertensive. She was down 20 minutes at home. She had pneumonia which lead to dehydration, which lead to aki (acute kidney injury), which lead to increased potassium which lead to cardiac arrest. She did have some twitching from the start in all limbs which was called myoclonic twitching from an anoxic encephalopathy (burst suppression pattern on eeg) clinical statement: 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: ARCTIC SUN GEL 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: amy gravley ; 8195 industrial blvd; covington, GA 30014 ; 7707846100
• MDR Report Key: 6348180
• MDR Text Key: 67933794
• Report Number: 1018233-2017-00599
• Device Sequence Number: 1
• Product Code: DWJ
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K142702
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,other

Reporter Occupation

• Type of Report: Initial
• Report Date: 01/31/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/21/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No

Device Operator

• 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 Received: 01/31/2017
• 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: 02/21/2017 Patient Sequence Number: 1