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

Catalog Number	317-03-02
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/14/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the ulcer on the side of the abdomen, would cause related to arctic gel pads.During use after a few hours using the therapy, they realized the patient had a few blisters on the side of the abdomen.It has developed over the next 2 weeks to be a grade iii ulcer.It was believed to be infected as the patient's abdomen was still open and fluids coming out of the abdomen wound and into this smaller one.They told me they used only one pad in the thoracic area, covering most of the back and one side where the blisters appeared.They also used both leg pads with no adverse reactions there.Per follow up information received via task on 03apr2025, it was suspected that the ulcer was caused by the gel pads.Silver hydrofibre (aquacel ag) medication was provided.Per sample evaluation results received via task on 14jul2025, it was reported that the hydrogel was peeled back from the corner of the right chest pad.
Additional Manufacturer Narrative
The initial reporter phone number provided is (b)(6).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 ulcer on the side of the abdomen, would cause related to arctic gel pads.During use after a few hours using the therapy, they realized the patient had a few blisters on the side of the abdomen.It has developed over the next 2 weeks to be a grade iii ulcer.It was believed to be infected as the patient's abdomen was still open and fluids coming out of the abdomen wound and into this smaller one.They told me they used only one pad in the thoracic area, covering most of the back and one side where the blisters appeared.They also used both leg pads with no adverse reactions there.Per follow up information received via task on 03apr2025, it was suspected that the ulcer was caused by the gel pads.Silver hydrofibre (aquacel ag) medication was provided.Per sample evaluation results received via task on 14jul2025, it was reported that the hydrogel was peeled back from the corner of the right chest pad.
Additional Manufacturer Narrative
The reported event was inconclusive because this investigation did not result in any additional findings and no sample was available for evaluation.This occurrence does not introduce a new hazard or harm.It represents a known failure mode that has been assessed in the product risk management file in accordance with applicable regulatory standards and internal procedures.The associated risks continue to be monitored as part of ongoing post-market activities in compliance with both regulatory requirements and local procedures.The labeling is found to be adequate.A review of the device history record did not show any problems or conditions that would have contributed to the reported issue.Correction: d, e, f, 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, 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 -1725056; 321 south taylor ave; suite 200; louisville CO 80027
• Manufacturer Contact: xeeroy rada ; 8195 industrial blvd; covington, GA 30014 ; 7707846100
• MDR Report Key: 22512843
• Report Number: 1018233-2025-05883
• Device Sequence Number: 18329459
• Product Code: DWJ
• UDI-Device Identifier: 10801741080040
• UDI-Public: (01)10801741080040(11)230721(17)250531(10)NGHT0569
• Combination Product (Y/N): N
• Initial Reporter Country: SP
• 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): 10/10/2025

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: 05/31/2025
• Device Catalogue Number: 317-03-02
• Device Lot Number: NGHT0569
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/14/2025
• Supplement Date Received by Manufacturer: 10/10/2025
• Initial Report FDA Received Date: 07/15/2025
• Supplement Report FDA Received Date: 10/15/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 07/21/2023
• 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