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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MEDIVANCE, INC. ¿ 1725056 ARCTICGEL PADS

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MEDIVANCE, INC. ¿ 1725056 ARCTICGEL PADS Back to Search Results
Device Problems Use of Device Problem (1670); Patient-Device Incompatibility (2682)
Patient Problems Death (1802); Peeling (1999); Skin Tears (2516)
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 while removing the arctic sun pads during postmortem on an (b)(6)year old, female patient, the patient¿s skin came off with the pads. The patient had been placed on the device post cardiac arrest for hypothermic management on (b)(6) 2019 at 7:20 pm. The patient had low blood pressure and was on multiple vasopressors. Therapy was discontinued on (b)(6) 2019 at 2:50 pm before the completion of therapy because the patient had expired. Approximately two hours after the patient expired, the pads were removed. Upon removal of the pads, the patient¿s skin came off with the pads. The nurse stated that skin checks were not being done every 2 hours. The patient¿s skin was not intact before the placement of the pads, which included dry, bilateral knees mottled, buttocks red, scattered bruising bilaterally to arms, abdominal area, and left lower anterior leg. There were also scratches on the left and right lower abdomen. The pads were discarded. The patient had a history of hyperlipidemia, hypertension, and pneumonia, which had been recently treated. The cause of death listed on the death certificate was healthcare acquired pneumonia and acute renal failure. Clinical review of attached photos: the photo labeled "northwest hospital case photo1¿ shows abdominal area and upper leg on the right side with multiple skin tears and mottling. Photo 2 labeled, "northwest hospital case photo 2" shows left upper leg area that has mottled skin on the outside of the thigh with bright red skin tears on the inner thigh area. The photo labeled ¿northwest hospital case photo 3¿ shows back of the left thigh. This is a large area that is bright red which appears that the skin peeled off. The last photo labeled, ¿northwest hospital case photo 4¿ shows the inner thigh area of both legs. This area is bright red showing a large area on the left thigh with missing skin. The right thigh is also bright red, but is a smaller area.
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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
yonic anderson
8195 industrial blvd
covington, GA 30014
MDR Report Key8682356
MDR Text Key147444156
Report Number1018233-2019-02983
Device Sequence Number1
Product Code DWJ
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type health professional,other,use
Reporter Occupation
Type of Report Initial,Followup
Report Date 07/17/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received06/10/2019
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer05/22/2019
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received07/01/2019
Was Device Evaluated by Manufacturer? Yes
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: 06/10/2019 Patient Sequence Number: 1