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

Catalog Number	317-09-02
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/01/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the (b)(6) hospital (b)(6), sd had experienced a defect with reference # 317-05 (lot # ngjx2721) arctic gel pad.When the nursing staff went to remove the wrapper on the sticky part of the pads it removes the entire sticky part of the pad, making them unable to use.They have the product and packaging saved from this.Please let them know what other information need from them.Per additional information received via mail on 01aug2025, they have the one item that they reported back on july 16 (ref # 317-05).Just yesterday, they had an issue with a different size pad, but the same issue as the one reported.This was ref # 317-09.When the staff removed the tab, just the tab popped off.The blue layer that was supposed to peel off did not peel off with the tab.The staff took all the sticky part off and used the rest of the pad but had to affix to patient using coban.They have just the sticky part and tab from this item as the pad itself was currently on a patient.
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 avera mckennan hospital in sioux falls, sd had experienced a defect with reference # (b)(4) (lot # ngjx2721) arctic gel pad.When the nursing staff went to remove the wrapper on the sticky part of the pads it removes the entire sticky part of the pad, making them unable to use.They have the product and packaging saved from this.Please let them know what other information need from them.Per additional information received via mail on 01aug2025, they have the one item that they reported back on july 16 (ref # (b)(4)).Just yesterday, they had an issue with a different size pad, but the same issue as the one reported.This was ref # (b)(4).When the staff removed the tab, just the tab popped off.The blue layer that was supposed to peel off did not peel off with the tab.The staff took all the sticky part off and used the rest of the pad but had to affix to patient using coban.They have just the sticky part and tab from this item as the pad itself was currently on a patient.
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.Two photo samples were received for evaluation.Visual inspection noted the following: * both photos show the hydrogel layer and blue liner for a thigh pad together, separated from the rest of the pad.The pull tab is shown in one photo to have been pulled off the liner and stuck back on.The foil packaging in the background shows lot number ngkq3487.The instructions-for-use 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.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.Refer to the capa for further action.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, ARCTIC GEL¿ 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: 22708454
• Report Number: 1018233-2025-06461
• Device Sequence Number: 21228753
• Product Code: DWJ
• UDI-Device Identifier: 00801741080104
• UDI-Public: (01)00801741080104(11)250515(17)270228(10)NGKQ3487
• Combination Product (Y/N): N
• Initial Reporter State: SD
• 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,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 Catalogue Number: 317-09-02
• Device Lot Number: NGKQ3487
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/01/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/01/2025
• Supplement Date Received by Manufacturer: 01/30/2026
• Initial Report FDA Received Date: 08/04/2025
• Supplement Report FDA Received Date: 02/05/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/15/2025
• 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