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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MEDIVANCE, INC. ¿ 1725056 ARCTIC SUN® TEMPERATURE MANAGEMENT SYSTEM, ARCTICGEL¿ PADS ARCTIC GEL PAD

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MEDIVANCE, INC. ¿ 1725056 ARCTIC SUN® TEMPERATURE MANAGEMENT SYSTEM, ARCTICGEL¿ PADS ARCTIC GEL PAD Back to Search Results
Catalog Number 317-07
Device Problem Material Separation (1562)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 12/28/2021
Event Type  malfunction  
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 the target temperature management case was started on (b)(6) 2021, for a severe traumatic brain injury (tbi) patient. The patient was treated with normothermia protocol with new medium sized arctic gel pads. On (b)(6) 2021, doctors found that the arctic gel pad layer had peeled away from all 4 gel pads on both legs and chest. The gel pads no longer had the ability to stick to the patient¿s skin, and it needs to be fixed with ties. The gel pads were stored at a room temperature of 20c to 24c in the storage. The gel pads were in good condition, with no signs of gel peeling prior to initiating therapy. The gel pads were not exposed to any liquids during patient care. It was mentioned that the patient temperature was difficult to control.
 
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Brand NameARCTIC SUN® TEMPERATURE MANAGEMENT SYSTEM, ARCTICGEL¿ PADS
Type of DeviceARCTIC GEL PAD
Manufacturer (Section D)
MEDIVANCE, INC. ¿ 1725056
321 s taylor ave
suite 200
louisville 80027
Manufacturer (Section G)
MEDIVANCE, INC. ¿ 1725056
321 s taylor ave
suite 200
louisville 80027
Manufacturer Contact
yonic anderson
8195 industrial blvd
covington 30014
7707846100
MDR Report Key13349458
MDR Text Key285410583
Report Number1018233-2022-00164
Device Sequence Number1
Product Code DWJ
Combination Product (y/n)N
Reporter Country CodeVM
PMA/PMN Number
K142702
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Other,Health Professional,Company Representative,Distributor
Reporter Occupation
Type of Report Initial,Followup
Report Date 05/26/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received01/25/2022
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue Number317-07
Device Lot NumberNGFS2837
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer01/20/2022
Is the Reporter a Health Professional? Yes
Date Manufacturer Received05/26/2022
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured06/11/2021
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: 01/25/2022 Patient Sequence Number: 1
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