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

Device Problem Insufficient Information (3190)

Patient Problems Swelling (2091); Complaint, Ill-Defined (2331)

Event Type  Injury  

Event Description

It was reported that as a result of using the device, the patient had developed a blister on the back of his thigh following treatment at 36 degrees.It was unknown whether the event is related to the device or whether his skin was already marked when the pads were placed.The patient, who was described as 'extremely sick' was predominantly nursed in the prone position during this treatment.No medical intervention was required.

Manufacturer Narrative

The investigation is still in progress.Once the investigation is complete, a supplemental report will be filed.

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.No sample received.

• Brand Name: ARCTIC GEL PADS
• Manufacturer (Section D): PRODUCTOS PARA EL CUIDADO DE LA SALUD; nogales, sonora ; MX
• Manufacturer (Section G): PRODUCTOS PARA EL CUIDADO DE LA SALUD; km. 7., carretera internacional; nogales, sonora 85621 ; MX 85621
• Manufacturer Contact: christy lewis ; 8195 industrial blvd.; covington, GA 30014 ; 7707846100
• MDR Report Key: 4963024
• MDR Text Key: 21833548
• Report Number: 1018233-2015-00242
• 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: User Facility,user facility
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 08/06/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/31/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 08/06/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention