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

Catalog Number 317-07-02

Device Problem Insufficient Information (3190)

Patient Problem Skin Erosion (2075)

Event Date 07/08/2016

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 during hypothermia treatment, the patient developed red pressure marks on the legs.The complainant also reported that the patient was not injured, and the marks eventually disappeared.However, a clinical review of the photo samples received noted that there was a break in the skin.

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 during hypothermia treatment, the patient developed red pressure marks on the legs.The complainant also reported that the patient was not injured, and the marks eventually disappeared.However, a clinical review of the photo samples received noted that there was a break in the skin.

Manufacturer Narrative

The device was not returned for evaluation.The manufacturer cannot use the photo received as a sample, as the photo is a picture of the patient's condition, and did not reveal any condition of the product that would have contributed to the reported issue.The investigators are not clinicians, and therefore are not qualified to investigate the photo.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.Photo sample received.

Event Description

It was reported that during hypothermia treatment, the patient developed red pressure marks on the legs.The complainant also reported that the patient was not injured, and the marks eventually disappeared.However, a clinical review of the photo samples received noted that there was a break in the skin.

• 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: janna parks ; 8195 industrial blvd; covington, GA 30014 ; 7707846100
• MDR Report Key: 5979748
• MDR Text Key: 55708541
• Report Number: 1018233-2016-01299
• Device Sequence Number: 1
• Product Code: DWJ
• Combination Product (y/n): N
• PMA/PMN Number: K142702
• 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,Followup,Followup
• Report Date: 10/17/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/27/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 317-07-02
• Was Device Available for Evaluation?: No
• Date Returned to Manufacturer: 09/15/2016
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/17/2016
• 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
• Patient Outcome(s): Other