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

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	08/01/2025
Type of Reportable Event	Malfunction
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 15th april.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 hairmyres hospital 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.
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 left chest pad present with no original packaging.Two photos were received for evaluation.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 the connector.Tubing for the pad noted no kinks present.The hydrogel layer was absent from the pad, and the pad surface was residually sticky.One returned photo confirms this issue as it shows the hydrogel layer peeling from a chest pad with the liner.No crushed dimples or signs of overlamination in the pad.One returned photo shows a box with lot number ngjs1987 on the sticker.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.Therefore, no additional action is required at this time.Capa # 9743815 has been opened for this failure.The initial reporter phone number provided is (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.

• 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 30014 ; 7707846100
• MDR Report Key: 22923915
• Report Number: 1018233-2025-07254
• Device Sequence Number: 13051931
• Product Code: DWJ
• UDI-Device Identifier: 00801741080067
• UDI-Public: (01)00801741080067(11)240709(17)260430(10)NGJS1987
• 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: 04/30/2026
• Device Catalogue Number: 317-05-02
• Device Lot Number: NGJS1987
• 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: 07/09/2024
• 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