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

Catalog Number	317-09-02
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Codes	Skin Discoloration (2074); Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581)
Date of Event	07/14/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The investigation is still in progress.Once the investigation is complete a supplemental report will be filed.Initial reporter phone number: (b)(6).Initial reporter zip: (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 the hydrogel surface was removed prior to usage causing patient skin damage.It was discovered that the patient had a large bluish area on the left side of the back, consistent with the area where the arctic gel pads were applied.The skin was likely frostbitten.When the pads were being applied to the patient, and the colleague attempted to remove the protective film from the upper body pad (on the left side), the hydrogel layer of the product also detached.Only the patient's back and side appear to have sustained possible frostbite.Incident occurred during use.No medical intervention was reported.
Event or Problem Description
It was reported that the hydrogel surface was removed prior to usage causing patient skin damage.It was discovered that the patient had a large bluish area on the left side of the back, consistent with the area where the arctic gel pads were applied.The skin was likely frostbitten.When the pads were being applied to the patient, and the colleague attempted to remove the protective film from the upper body pad (on the left side), the hydrogel layer of the product also detached.Only the patient's back and side appear to have sustained possible frostbite.Incident occurred during use.It was unknown what medical intervention was reported.Per additional information received via mail on 04sep2025, in this case, electrodes were placed on the patient and the patient sustained injuries.The injuries have healed on their own and the patient has recovered.It was both a product defect as the gel was loose and a user error as these damaged electrodes should not have been placed on the patient.The entire treatment was done with the same electrodes, and the injury was not discovered until after the arctic sun treatment was completed.
Additional Manufacturer Narrative
The initial reporter's zip code: (b)(6).The initial reporter's phone number: (b)(6).The reported issue was inconclusive as the issue was not reproduced on the representative sample returned for evaluation and the investigation did not result in any additional findings.The root cause of the reported issue could not be identified.Visual evaluation of the returned sample noted one unopened large arctic gel pad present in original foil 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.- hydrogel was intact with pads and not separated.- no crushed dimples or signs of overlamination in the pads.- the pull tabs on the chest pads were not placed with their lines on the edge of the release liner.- evidence of pad cut misalignment was seen on all pads, with dimples outside the pad outlines.The sample meets specifications 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.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.Therefore, no additional action is required at this time.Capa 9743815 has been opened for this failure.Corrections: d, h.Udi format updated with available product information per gudid.H11: sections 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 -1725056; 321 south taylor ave; suite 200; louisville CO 80027
• Manufacturer (Section G): C.R. BARD INC. (COVINGTON) -1018233; 8195 industrial blvd; suite 200; covington GA 30014
• Manufacturer Contact: xeeroy rada ; 8195 industrial blvd; covington, GA 30014 ; 7707846100
• MDR Report Key: 22843273
• Report Number: 1018233-2025-06882
• Device Sequence Number: 4849226
• Product Code: DWJ
• UDI-Device Identifier: 00801741080104
• UDI-Public: (01)00801741080104(11)241106(17)260930(10)NGJX0197
• Combination Product (Y/N): N
• Initial Reporter Country: NO
• PMA/510(K) Number: K142702
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 02/18/2026

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 09/30/2026
• Device Catalogue Number: 317-09-02
• Device Lot Number: NGJX0197
• 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: 08/12/2025
• Supplement Date Received by Manufacturer: 02/18/2026
• Initial Report FDA Received Date: 08/19/2025
• Supplement Report FDA Received Date: 02/25/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/06/2024
• 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