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

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.

• 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: 6069236
• MDR Text Key: 58844166
• Report Number: 1018233-2016-01513
• Device Sequence Number: 1
• Product Code: DWJ
• Combination Product (y/n): N
• Reporter Country Code: UK
• PMA/PMN Number: K142702
• Number of Events Reported: 1
• 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 Received: 11/01/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No

Device Operator

• Device Expiration Date: 06/30/2017
• Device Catalogue Number: 317-09-02
• Device Lot Number: NGAT1460
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/27/2016
• Is the Reporter a Health Professional?: Yes

Was the Report Sent to FDA?

• Event Location: No Information
• Date Manufacturer Received: 11/17/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/12/2016
• 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