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

Catalog Number	317-05-02
Medical Device Problem Code	Fitting Problem (2183)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/28/2025
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 port on the upper left body of arctic gel pad was deformed and could not be connected, so another set was opened and used.
Event or Problem Description
It was reported that the connection port on the upper left body of arctic gel pad was deformed and could not be connected, so another set was opened and used.Per follow up information received via task on 05aug2025, sample will be returned, and they let know the tracking id in near future.No impact to the patient due to the use of the product.
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 small arctic gel right chest pad present with no original packaging.Visual inspection noted the following: no obvious visible defects such as cuts or tears in the foam.Both ends of the connector were deformed.The pad could not be connected to a fluid delivery line.Tubing for the pad noted no kinks present.Hydrogel was intact with pad and not separated.No crushed dimples or signs of overlamination in the pad.The labeling is found to be adequate.A review of the device history record did not show any problems or conditions that would have contributed to the reported issue.No additional actions can be taken at this time.Correction: d,h.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 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: 22675979
• Report Number: 1018233-2025-06352
• Device Sequence Number: 13153132
• Product Code: DWJ
• UDI-Device Identifier: 00801741080067
• UDI-Public: (01)00801741080067(11)250122(17)260930(10)NGJX6061
• 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): 01/30/2026

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: 09/30/2026
• Device Catalogue Number: 317-05-02
• Device Lot Number: NGJX6061
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/29/2025
• Supplement Date Received by Manufacturer: 01/30/2026
• Initial Report FDA Received Date: 07/31/2025
• Supplement Report FDA Received Date: 02/05/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/22/2025
• 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