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

Catalog Number	317-05
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/06/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The investigation is still in progress.Once the investigation is complete a supplemental report will be filed.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 connection part of the arctic gel pad was crushed and deformed, so it could not be connected to the circulation hose.The customer wishes to return it for an exchange.
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 2 arctic gel chest pads and 1 thigh gel pad present with no original packaging.One photo sample was returned for evaluation.Visual inspection noted the following: * no obvious visible defects such as cuts or tears in the foam.* photo and evaluation of the left chest pad show crushed connector.* tubing for all the pads noted no kinks present.* hydrogel was intact with pad and not separated.* no crushed dimples or signs of overlamination in the pads.*liner on the left chest pad been removed and then put back in place.*orange debris seen inside damaged side of the connector, same color as fdl o ring.The reported issue could not be verified without further testing.The pad could not be connected to the fluid delivery line due to the crushed connector noted in the visual evaluation.The sample does not meet specifications per ip7602996 rev 13 which states "all components must be free of damages like cracks, holes, tears, separations or perforations." 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.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 connection part of the arctic gel pad was crushed and deformed, so it could not be connected to the circulation hose.The customer wishes to return it for an exchange.Per follow up information received via task on (b)(6)2025, the number of products affected was 1.Let know the tracking information when the sample is ready for the shipment.

• 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 CO 80027
• Manufacturer Contact: xeeroy rada ; 8195 industrial blvd; covington, GA 30014 ; 7707846100
• MDR Report Key: 23301295
• Report Number: 1018233-2025-09164
• Device Sequence Number: 13271198
• Product Code: DWJ
• UDI-Device Identifier: 00801741080067
• UDI-Public: (01)00801741080067(11)240719(17)260430(10)NGJS3481
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K142702
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,User Facility
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 04/24/2026

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: 04/30/2026
• Device Catalogue Number: 317-05
• Device Lot Number: NGJS3481
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/07/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/07/2025
• Supplement Date Received by Manufacturer: 04/24/2026
• Initial Report FDA Received Date: 10/15/2025
• Supplement Report FDA Received Date: 04/28/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/19/2024
• 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