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

Catalog Number	317-09-02
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/26/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The reported event was confirmed.The root cause of the reported issue could not be identified.Capa # 9743815 has been opened for this failure.Refer to the capa for further action.Visual evaluation of the returned sample noted one opened] large arctic gel pad kit present with original packaging label.Visual inspection noted the following: * no obvious visible defects such as cuts or tears in the foam.* no visible chips or deformities at the ends of all connectors.* tubing for all the pads noted no kinks present.* the hydrogel layer had peeled from the right thigh pad with the liner bundled on top.The hydrogel layer of the right chest pad peeled from the edge when the liner was pulled by the pull tab.Hydrogel was intact with pad and not separated for all other pads.* no crushed dimples or signs of overlamination in the pads.The sample does not meet specifications which states "after laminating the pad (before of the operation of silhouette cut of the pad), peel off the protector that covers the hydrogel, verify that the hydrogel is not peeling off with the protector, the hydrogel must be attached to the laminating film (perform this activity, peeling the protector prior to the sealing area of the pad)." the labeling is found to be adequate.A review of the device history record and manufacturing controls did not show any problems or conditions that would have contributed to the reported issue.Udi format updated with available product information per gudid.Initial reporter name: (b)(6).H11: section a through f - the information provided by bd represents all the known information at this time.Despite good faith efforts to obtain additional information, the complainant / reporter was unable or unwilling to provide any further patient, product, or procedural details to bd.
Event or Problem Description
It was reported that the arctic gel pad hydrogel peeled off the pad with the liner and was not able to be used.Had to open new pads to treat the patient.Pad coverage was not appropriate with gel peeling off.

• Brand Name: ARCTIC SUN® TEMPERATURE MANAGEMENT SYSTEM, ARCTICGEL¿ PADS
• Common Device Name: ARCTIC GEL PADS COOLING KIT
• 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: xeeroy rada ; 8195 industrial blvd; covington, GA 30014 ; 7707846100
• MDR Report Key: 23301116
• Report Number: 1018233-2025-09190
• Device Sequence Number: 13268968
• Product Code: DWJ
• UDI-Device Identifier: 00801741080104
• UDI-Public: (01)00801741080104(11)240809(17)260531(10)NGJT0995
• Combination Product (Y/N): N
• Initial Reporter State: MO
• Initial Reporter Country: US
• PMA/510(K) Number: K142702
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Health Professional,User Facility
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 10/13/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 05/31/2026
• Device Catalogue Number: 317-09-02
• Device Lot Number: NGJT0995
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/23/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/10/2025
• Initial Report FDA Received Date: 10/15/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/09/2024
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown