MAUDE Adverse Event Report: MEDIVANCE, INC. ¿ 1725056 UNKNOWN ARCTICGEL PADS; ARCTIC GEL PADS

Model Number 50000000

Device Problems Nonstandard Device (1420); Patient Device Interaction Problem (4001)

Patient Problems Sepsis (2067); Skin Tears (2516); Blister (4537)

Event Date 04/12/2023

Event Type  Injury  

Event Description

It was reported that nurse reported kin issue with patient on the arctic sun device.Nurse stated that the patient was septic, and skin blistered and peeled off.They tried to obtain water temperature and patient temperature information or device serial number, but nurse did not have any data available.Noted they would need to have them download this patient therapy data for review.Per additional information received via email on 13apr2023, they went to investigate skin issue.Nurse stated when patient came in that the skin was very dry looking and they did not put pads on and instead used ice packs, then arctic sun was put on by night shift.Nurse stated patient had cancer and came in because of sepsis and that was diagnosed with necrotizing fasciitis on patient abdomen as of today.Patient was on dialysis when they arrived and did have a large area of skin removed from the left inner thigh region.Nurse did note blisters on patient lower legs and left arm.Charge nurse showed them a picture of the pad with the skin stuck on it.The case was started at 19:21 on (b)(6) 2023 and then ended 14:12 (b)(6) 2023.On the case it appeared they stopped therapy at 7:10 in the morning and machine was not turned off till 14:12.Patient temperature had increased from 37 to 39 during that time frame.Nurse was unable to find out when last skin check was done before removing the pads.

Manufacturer Narrative

The investigation is still in progress.Once the investigation is complete a supplemental report will be filed.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 Description

It was reported that nurse reported kin issue with patient on the arctic sun device.Nurse stated that the patient was septic and skin blistered and peeled off.They tried to obtain water temperature and patient temperature information or device serial number, but nurse did not have any data available.Noted they would need to have them download this patient therapy data for review.As per additional information received via email on 13apr2023, they went to investigate skin issue.Nurse stated when patient came in that the skin was very dry looking and they did not put pads on and instead used ice packs, then arctic sun was put on by night shift.Nurse stated patient had cancer and came in because of sepsis and that was diagnosed with necrotizing fasciitis on patient abdomen as of today.Patient was on dialysis when they arrived and did have a large area of skin removed from the left inner thigh region.Nurse did note blisters on patient lower legs and left arm.Charge nurse showed them a picture of the pad with the skin stuck on it.The case was started at 19:21 on (b)(6) 2023 and then ended 14:12 (b)(6) 2023.On the case it appeared they stopped therapy at 7:10 in the morning and machine was not turned off till 14:12.Patient temperature had increased from 37 to 39 during that time frame.Nurse was unable to find out when last skin check was done before removing the pads.

Manufacturer Narrative

The reported event was inconclusive because no sample was returned.A potential root cause for this failure could be due to "materials that are contacting the patient¿s intact skin are not biocompatible".The device history record review could not be performed without a lot number.The product catalog number and the lot number for this device are unknown.Therefore, bd is unable to determine the associated labeling to review.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.H3 other text: the device was not returned.

• Brand Name: UNKNOWN ARCTICGEL PADS
• Type of Device: 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: 16867806
• MDR Text Key: 314544622
• Report Number: 1018233-2023-03125
• Device Sequence Number: 1
• Product Code: DWJ
• UDI-Device Identifier: 00801741080142
• UDI-Public: (01)00801741080142
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K142702
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Health Professional,User Facility
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 10/12/2023

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
• Device Operator: Health Professional
• Device Model Number: 50000000
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 04/12/2023
• Initial Date FDA Received: 05/04/2023
• Supplement Dates Manufacturer Received: 10/12/2023
• Supplement Dates FDA Received: 10/13/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other