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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MEDIVANCE, INC. ¿ 1725056 UNKNOWN ARCTICGEL PADS ARCTIC SUN GEL PADS

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MEDIVANCE, INC. ¿ 1725056 UNKNOWN ARCTICGEL PADS ARCTIC SUN GEL PADS Back to Search Results
Catalog Number UNKNOWN
Device Problems Overheating of Device (1437); Patient-Device Incompatibility (2682)
Patient Problems Burn(s) (1757); Fever (1858); Low Blood Pressure/ Hypotension (1914); Sepsis (2067); Skin Irritation (2076); Tissue Damage (2104)
Event Type  Injury  
Manufacturer Narrative
The investigation is still in progress. Once the investigation is complete, a supplemental report will be filed. The device was not returned.
 
Event Description
It was reported that the patient developed blisters under each arctic sun pad after the fifth day of use. The patient required a readmission for wound treatment. The patient required surgical debridement and was transferred to a burn center for further treatment. The complainant states that the pads were used for normothermia. The facility has a hypothermia protocol but does not have a normothermia protocol. Per additional information received from the complainant via email on 8-feb-2018: skin checks were not documented clearly and the staff verbally confirmed that skin checks were done at least every four hours. They blisters were discovered on (b)(6) 2019. The blisters were deflated and partially unroofed. There was a 4cm x 4cm blister on the left buttock, deflated. The upper left hip area had a scattering of deflated blisters in an area measuring 4 cm x 8 cm. The left lateral hip/buttock region had 2 blisters measuring 1cm x 1. 5cm and 1 cm x 2 cm. The left lateral back had an unroofed blister measuring 0. 5cm x 7 cm. All the blisters were covered with mepilex border dressing. The arctic sun was prescribed for normothermia treatment related to fever uncontrolled with ice packs and antipyretic medications for 18 plus hours. The patient had been admitted for alcoholic pancreatitis and was septic. Also, she was hypotensive and was given levophed for several days.
 
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Brand NameUNKNOWN ARCTICGEL PADS
Type of DeviceARCTIC 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
yonic anderson
8195 industrial blvd
covington, GA 30014
7707846100
MDR Report Key8357361
MDR Text Key136758871
Report Number1018233-2019-00917
Device Sequence Number1
Product Code DWJ
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K142702
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type health professional,other,use
Reporter Occupation Non-Healthcare Professional
Type of Report Initial,Followup
Report Date 03/21/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received02/21/2019
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue NumberUNKNOWN
Was Device Available for Evaluation? No
Is the Reporter a Health Professional?
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received03/04/2019
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 Treatment Data
Date Received: 02/21/2019 Patient Sequence Number: 1
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