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

Catalog Number UNKNOWN

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Necrosis (1971); Pain (1994); Skin Discoloration (2074); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Date 08/15/2022

Event Type  Injury  

Manufacturer Narrative

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

Event Description

It was reported that hypoxic ischemic encephalopathy baby had fat necrosis while being treated with the arctic gel pads.It was unknown what medical intervention was provided.As per follow up information received on (b)(6) 2022, infant with large area of discoloration on the back with multiple elevated nodules consistent with subcutaneous fat necrosis, likely related to cooling.Triglyceride level obtained, reassuring internal carotid artery.Continues to be mildly elevated, at risk for hypercalcemia, will need monitoring.Infant appearing in pain when back touched, improved with prn tylenol , received 2 doses in last 24 hours.Pediatrician to continue to monitor closely.Pediatrician to follow calcium at 30, 45 and 60 days of life.

Manufacturer Narrative

The reported event was inconclusive because no sample was returned.A potential root cause for this failure could be ¿materials that are contacting the patient¿s intact skin are not biocompatible".The dhr review could not be performed without a lot number.Based on the results of the investigation, no additional actions are needed.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 of 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.

Event Description

It was reported that hypoxic ischemic encephalopathy baby had fat necrosis while being treated with the arctic gel pads.It was unknown what medical intervention was provided.As per follow up information received on 24aug2022, infant with large area of discoloration on the back with multiple elevated nodules consistent with subcutaneous fat necrosis, likely related to cooling.Triglyceride level obtained, reassuring internal carotid artery.Continues to be mildly elevated, at risk for hypercalcemia, will need monitoring.Infant appearing in pain when back touched, improved with prn tylenol , received 2 doses in last 24 hours.Pediatrician to continue to monitor closely.Pediatrician to follow calcium at 30, 45 and 60 days of life.

• Brand Name: ARCTIC GEL PADS
• Type of Device: UNKNOWN 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: 15321180
• MDR Text Key: 298894721
• Report Number: 1018233-2022-06778
• Device Sequence Number: 1
• Product Code: DWJ
• 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: 11/07/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/30/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/08/2022
• 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): Required Intervention