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

Catalog Number	318-01
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/27/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The investigation is still in progress.Once the investigation is complete a supplemental report will be filed.The complete initial reporter facility name 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.
Event or Problem Description
It was reported that there was a leakage immediately after opening and use of an arctic gel pad.
Additional Manufacturer Narrative
The reported event was inconclusive because no sample was available for evaluation and further investigation did not result in any additional findings.Baw7650746, rev 1 was reviewed for this investigation.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.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 there was a leakage immediately after opening and use of an arctic gel pad.Per follow up information received via task on 09dec2024, the device was sent in for a bd-approved facility for evaluation.The issue was not resolved.New one was used.Patient complete therapy on the new device.No impact to the patient.

• Brand Name: ARCTIC SUN® TEMPERATURE MANAGEMENT SYSTEM, ARCTICGEL¿ PADS
• Common Device Name: ARCTICGEL 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: 20851860
• Report Number: 1018233-2024-07780
• Device Sequence Number: 15463717
• Product Code: DWJ
• UDI-Device Identifier: 00801741080128
• UDI-Public: (01)00801741080128(11)221222(17)241130(10)NGGZ0940
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K142702
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,User Facility
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 01/16/2025

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: 11/30/2024
• Device Catalogue Number: 318-01
• Device Lot Number: NGGZ0940
• 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: 11/29/2024
• Supplement Date Received by Manufacturer: 01/16/2025
• Initial Report FDA Received Date: 12/05/2024
• Supplement Report FDA Received Date: 01/21/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 12/22/2022
• 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