MAUDE Adverse Event Report: MEDIVANCE, INC. ¿ 1725056 ARCTIC SUN® TEMPERATURE MANAGEMENT SYSTEM, ARCTICGEL¿ PADS; ARCTICGEL COOLING KIT MEDIUM 2PADS

Catalog Number	317-07-02
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581)
Date of Event	05/16/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The reported issue was confirmed.The root cause of the reported issue could not be identified.Visual evaluation of the returned sample noted one opened medium arctic gel left chest pad present with no original packaging.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.* part of the hydrogel layer had peeled off the pad surface with the liner, tearing from the part of the layer that remained on the pad.* no crushed dimples or signs of over lamination in the pads.The sample does not meet specifications per over lamination rev 13 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)." a review of the risk document, (b)(4), revision 22, was performed for this investigation.The reported event is addressed in step # 20.This occurrence does not introduce a new hazard or harm.It represents a known failure mode that has been assessed in the product risk management file in accordance with applicable regulatory standards and internal procedures.The associated risks continue to be monitored as part of ongoing post-market activities in compliance with both regulatory requirements and local procedures the instructions-for-use under baw7667062 rev 0 are found to be adequate.The ifu currently instructs the user on the proper method to use this device to avoid undue injury to the patient and damage to the product.Per the ifu: "place the pads on healthy, clean skin only.Remove any creams or lotions from patient¿s skin before pad application.Remove the release liner from each pad and apply to the appropriate area.The pads may be overlapped or folded adhesive-to-adhesive to achieve proper placement.The pads may be removed and reapplied if necessary.The pad surface must be contacting the skin for optimal energy transfer efficiency.Place pads to allow for full respiratory excursion." 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.Therefore, no additional action is required at this time.Capa # 9743815 has been opened for this failure.Refer to the capa for further action.Udi format updated with available product information per gudid.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 rn opened brand new arctic sun pad and the adhesive cover was not on the pad correctly.The sticky material was defective.Per follow up information received via mail on 10jun2025, they received one kit which they sent back with sample.Recently they received another defected pad and in need for another kit to mail it back.Sample will be returning.

• Brand Name: ARCTIC SUN® TEMPERATURE MANAGEMENT SYSTEM, ARCTICGEL¿ PADS
• Common Device Name: ARCTICGEL COOLING KIT MEDIUM 2PADS
• Manufacturer (Section D): MEDIVANCE, INC. ¿ 1725056; 321 s taylor ave; suite 200; louisville 80027
• Manufacturer (Section G): MEDIVANCE -1725056; 321 south taylor ave; suite 200; louisville CO 80027
• Manufacturer Contact: xeeroy rada ; 8195 industrial blvd; covington, GA 30014 ; 7707846100
• MDR Report Key: 22926152
• Report Number: 1018233-2025-07259
• Device Sequence Number: 15732458
• Product Code: DWJ
• UDI-Device Identifier: 00801741080081
• UDI-Public: (01)00801741080081(11)250330(17)270131(10)NGKP2765
• Combination Product (Y/N): N
• Initial Reporter State: CT
• 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): 08/28/2025

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 Catalogue Number: 317-07-02
• Device Lot Number: NGKP2765
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/26/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/27/2025
• Initial Report FDA Received Date: 08/29/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/30/2025
• 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