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U.S. Department of Health and Human Services

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

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MEDIVANCE, INC. ¿ 1725056 ARCTICSUN GEL PADS ARCTIC SUN GEL PADS Back to Search Results
Device Problem Patient-Device Incompatibility (2682)
Patient Problems Sepsis (2067); No Consequences Or Impact To Patient (2199); Skin Tears (2516); Fluid Discharge (2686)
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 there was a patient-device incompatibility on the arctic sun device. There was a palm sized skin tear from the arctic sun pads with serous drainage. The patient was 3rd spacing from possible sepsis which was a contributing factor. Per follow up, therapy was not completed on the device and the device was not swapped.
 
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Brand NameARCTICSUN GEL 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 Key9607088
MDR Text Key187229790
Report Number1018233-2020-00429
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
Reporter Occupation Other Health Care Professional
Type of Report Initial,Followup
Report Date 02/05/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received01/20/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received02/03/2020
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

Patient Treatment Data
Date Received: 01/20/2020 Patient Sequence Number: 1
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