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

Catalog Number	317-07-02
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/04/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The reported issue was confirmed.The root cause of the reported issue could not be identified.Capa # 9743815 has been opened for this failure.Refer to the capa for further action.Three photos were received for evaluation.Visual inspection noted the following: * one photo shows the label on the pad pouch, lot number ngjx2427.* two photos confirm the reported issue, as they show a chest pad with liner partially peeled off and bubbles underneath the hydrogel where the hydrogel layer had lifted from the pad surface.The sample does not meet specifications per (b)(4) 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)." the instructions-for-use are 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.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 on (b)(6), they received negative feedback from their customers regarding the quality of the arctic gel pads.They reported that when they opened a new pack, the gel pad was in very poor condition flabby, with the hydrogel layer nearly peeling off.Per follow up information received via mail on 19mar2025, nurse had thrown away the gel pad, so they don¿t have the sample to return to bd approved facility.The issue was resolved.Since that was an emergency and they did not have another gel pad, so the doctor decided to use the flabby gel pad for patient.

• 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, GA 30014 ; 7707846100
• MDR Report Key: 22842326
• Report Number: 1018233-2025-06881
• Device Sequence Number: 14658329
• Product Code: DWJ
• UDI-Device Identifier: 10801741080088
• UDI-Public: (01)10801741080088(11)250111(17)260930(10)NGJX2427
• Combination Product (Y/N): N
• Initial Reporter Country: VM
• PMA/510(K) Number: K142702
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 08/18/2025

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: 317-07-02
• Device Lot Number: NGJX2427
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/04/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/15/2025
• Initial Report FDA Received Date: 08/19/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/11/2025
• 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