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	Material Separation (1562)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/15/2025
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.Visual evaluation of the returned sample noted one unopened small arctic gel pad kit present with original packaging, and three opened pads from a small kit 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 all connectors.Tubing for all the pads noted no kinks present.The hydrogel layer peeled back with the liner on the left thigh pad from the opened kit.Hydrogel was intact with pad and not separated on all other pads.No crushed dimples or signs of overlamination in the pads.The instructions-for-use were reviewed for this investigation and 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: "place the pads on healthy, clean skin only.Remove any creams or lotions from patient¿s skin before pad application.Remove the release liner from each pad and apply to the appropriate area.The pads may be overlapped or folded adhesive-to-adhesive to achieve proper placement.The pads may be removed and reapplied if necessary.The pad surface must be contacting the skin for optimal energy transfer efficiency.Place pads to allow for full respiratory excursion." 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.Initial reporter phone: (b)(6).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 they had an issue with arctic gel pad.End user was reporting that the adhesive was coming off when removing the cellophane wrapping, they have quarantined the product and 2 others with the same lot number (ngjw1496) and would appreciate if they could arrange collection for investigation and replacement of these.Per follow up information received via mail on 22apr2025, the faulty product was noted on the (b)(6).The procurement department has the product, if they would liaise with them to collect.The sample was never attached to the patient, so no risks attached.The patient was unharmed, thankfully they had another set of pads to use.Per follow up information received via task on 15may2025, they have the actual item and one unopened item from the same batch there at central stores in (b)(6) as confirmed in e-mail.The issue was identified during preparation.Per sample evaluation results on 01aug2025, pads from two lots were received for this complaint.The sample bags contained three opened pads from lot ngjw1496, one unopened set from lot ngjw1496, and one opened chest pad with a lot ngjs1987 sticker.

• 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: 22923927
• Report Number: 1018233-2025-07256
• Device Sequence Number: 9162637
• Product Code: DWJ
• UDI-Device Identifier: 00801741080067
• UDI-Public: (01)00801741080067(11)241031(17)260831(10)NGJW1496
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• PMA/510(K) Number: K142702
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 08/28/2025

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: 08/31/2026
• Device Catalogue Number: 317-05-02
• Device Lot Number: NGJW1496
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/30/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/27/2025
• Initial Report FDA Received Date: 08/29/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/31/2024
• 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