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

Model Number	38301
Medical Device Problem Codes	Expiration Date Error (2528); Device Handling Problem (3265)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/12/2022
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that small set of arctic gel pads were opened and gel came off from the pad rendering it unusable.Nurse replaced with universal pad for therapy.Nurse noticed petechiae on skin under pads after removal.The nurse noted that the universal pads were expired but unable to confirm expiration date of the pads used.Multiple adjustments were made to device during therapy.Per follow up information received via email on 14apr2022, the lot number was ngen0469.The petechia was found across the patient abdominal area.The skin condition before pads were applied was clear with no issues.The therapy was stopped into 7 hours of rewarming phase.No medical intervention was taken, the pads were removed from patient and they continued to monitor.
Additional Manufacturer Narrative
The investigation is still in progress.Once the investigation is complete a supplemental report will be filed.The device was not returned.
Event or Problem Description
It was reported that small set of arctic gel pads were opened and gel came off from the pad rendering it unusable.Nurse replaced with universal pad for therapy.Nurse noticed petechiae on skin under pads after removal.The nurse noted that the universal pads were expired but unable to confirm expiration date of the pads used.Multiple adjustments were made to device during therapy.Per follow up information received via email on 14apr2022, the lot number was ngen0469.The petechia was found across the patient abdominal area.The skin condition before pads were applied was clear with no issues.The therapy was stopped into 7 hours of rewarming phase.No medical intervention was taken, the pads were removed from patient and they continued to monitor.
Additional Manufacturer Narrative
Upon further review, bd has determined this event is not reportable.The information provided does not reasonably suggest that the event may have caused or contributed to a reportable malfunction of the device or a death/serious injury of a patient, user or other person.Therefore this event is deemed not reportable per 21 cfr part 803.Pminnarasi 11jul2022.H3 other text : the device was not returned.

• 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: juan velez ; 8195 industrial blvd; covington 30014 ; 7707846100
• MDR Report Key: 14309642
• Report Number: 1018233-2022-03384
• Device Sequence Number: 14661005
• Product Code: NNX
• UDI-Device Identifier: 00801741071225
• UDI-Public: (01)00801741071225
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• 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): 07/11/2022

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: Lay User/Patient
• Device Expiration Date: 01/31/2022
• Device Model Number: 38301
• Device Catalogue Number: 317-00-04
• Device Lot Number: NGEN0469
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 04/12/2022
• Supplement Date Received by Manufacturer: 06/29/2022
• Initial Report FDA Received Date: 05/06/2022
• Supplement Report FDA Received Date: 07/12/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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