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

Catalog Number	318-01-04
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/02/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the reporting two events with arctic sun device 318-01.Hydrogel pulled from pad when attempting to remove liner during preparation for patient use on (b)(6) 2025.Both pads available for return.Lot ngjx2716 and lot nghy1330.
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 arctic gel small universal pad present with 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 the connector.Tubing for the pad noted no kinks present.Hydrogel layer was absent from the pad.The pad surface was residually sticky.No crushed dimples or signs of over lamination in the pad.The sample does not meet specifications per (b)(4) rev 7 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 instructions-for-use were reviewed and were 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: "the pad surface must be contacting the skin for optimal energy transfer efficiency.The small universal pads are provided with a cloth liner over the hydrogel.The pads may be used with the cloth liner in place or removed to expose the hydrogel adhesive.If the cloth liner is used, secure the pads with the velcro straps to ensure good contact with the skin.The pads may be removed and reapplied if necessary." 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.

• Brand Name: ARCTIC SUN® TEMPERATURE MANAGEMENT SYSTEM, ARCTICGEL¿ PADS
• Common Device Name: ARCTIC GEL PADS
• 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 30014 ; 7707846100
• MDR Report Key: 22771321
• Report Number: 1018233-2025-06646
• Device Sequence Number: 9120521
• Product Code: DWJ
• UDI-Device Identifier: 00801741080128
• UDI-Public: (01)00801741080128(11)241126(17)260930(10)NGJX2716
• Combination Product (Y/N): N
• Initial Reporter State: PA
• 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): 08/08/2025

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: 09/30/2026
• Device Catalogue Number: 318-01-04
• Device Lot Number: NGJX2716
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/02/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/07/2025
• Initial Report FDA Received Date: 08/11/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/26/2024
• 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