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U.S. Department of Health and Human Services

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

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MEDIVANCE, INC. ¿ 1725056 ARCTICSUN GEL PADS ARCTIC GEL PAD Back to Search Results
Catalog Number 318-02
Device Problems Patient-Device Incompatibility (2682); Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Necrosis (1971); Injury (2348); Burn, Thermal (2530)
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 an infant patient developed fat necrosis to the skin during arctic sun therapy. Additional information was received from account manager on 18feb2020 that the pad had been discarded. The infant was noted to be (b)(6) at the time of treatment. The wound ostomy nurse had assessed the patient and a kenalog cream was applied to the injury. The complainant noted that the infant had been repositioned every four hours, per protocol.
 
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Brand NameARCTICSUN GEL PADS
Type of DeviceARCTIC GEL PAD
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 Key9780691
MDR Text Key188140200
Report Number1018233-2020-01486
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 04/02/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received03/03/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue Number318-02
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer02/13/2020
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received03/30/2020
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: 03/03/2020 Patient Sequence Number: 1
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