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

Device Problem Device Operates Differently Than Expected (2913)

Patient Problems Erythema (1840); Swelling (2091); Skin Tears (2516); Fluid Discharge (2686)

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 by the nurse that during therapy, the patient allegedly experienced skin tears as a result of the pads. It was later reported, that during the re-warm phase of therapy, superficial skin tears were found on the inner thigh, along the edges of the pad. The areas with broken skin were red/pinkish in color and leaking fluid; however, therapy was continued after the skin tears were discovered. No medical intervention was reported; however, skin checks were performed every four hours. It was noted that the patient had blisters on the abdomen and other areas of the body before arctic sun treatment began. The patient was very swollen and on vasopressors.

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). 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 by the nurse that during therapy, the patient allegedly experienced skin tears as a result of the pads. It was later reported, that during the re-warm phase of therapy, superficial skin tears were found on the inner thigh, along the edges of the pad. The areas with broken skin were red/pinkish in color and leaking fluid; however, therapy was continued after the skin tears were discovered. No medical intervention was reported; however, skin checks were performed every four hours. It was noted that the patient had blisters on the abdomen and other areas of the body before arctic sun treatment began. The patient was very swollen and on vasopressors.

• Brand Name: ARCTIC GEL PADS
• Type of Device: ARCTICSUN 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: 6309323
• MDR Text Key: 66761119
• Report Number: 1018233-2017-00344
• 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,Followup
• Report Date: 02/08/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/07/2017
• 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: 02/08/2017
• 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: 02/07/2017 Patient Sequence Number: 1