MAUDE Adverse Event Report: MEDIVANCE, INC. ¿ 1725056 ARTICGEL PADS; ARCTIC SUN GEL PADS

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Reaction (2414)

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.

Event Description

It was reported that two patients allegedly have had reactions to the gel pads where the skin turned bright red, resembling that of a sunburn.It was noted that the facility uses sage products to wash the patients which has chlorhexidine.The complainant was later advised by the medical support services team that some patients may have adverse reactions to chlorhexidine.

Manufacturer Narrative

Per additional information received from the complainant, this event was determined to be not reportable.The device was not returned.

Event Description

It was reported that two patients allegedly have had reactions to the gel pads where the skin turned bright red, resembling that of a sunburn.It was noted that the facility uses sage products to wash the patients which has chlorhexidine.The complainant was later advised by the medical support services team that some patients may have adverse reactions to chlorhexidine.

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 patients 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).

Event Description

It was reported that two patients allegedly have had reactions to the gel pads where the skin turned bright red, resembling that of a sunburn.It was noted that the facility uses sage products to wash the patients which has chlorhexidine.The complainant was later advised by the medical support services team that some patients may have adverse reactions to chlorhexidine.

• Brand Name: ARTICGEL PADS
• Type of Device: ARCTIC SUN GEL PADS
• Manufacturer (Section D): MEDIVANCE, INC. ¿ 1725056; 321 s taylor ave; louisville CO 80027
• Manufacturer (Section G): MEDIVANCE, INC. ¿ 1725056; 321 s taylor ave; louisville CO 80027
• Manufacturer Contact: amy gravley ; 8195 industrial blvd; covington, GA 30014 ; 7707846100
• MDR Report Key: 6805157
• MDR Text Key: 83058231
• Report Number: 1018233-2017-04315
• Device Sequence Number: 1
• Product Code: DWJ
• Combination Product (y/n): N
• Reporter Country Code: CA
• PMA/PMN Number: K142702
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,other
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 10/24/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 07/27/2017
• Initial Date FDA Received: 08/18/2017
• Supplement Dates Manufacturer Received: 10/17/2017; 10/23/2017
• Supplement Dates FDA Received: 10/20/2017; 10/24/2017
• 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 Sequence Number: 1
• Patient Outcome(s): Other