MAUDE Adverse Event Report: CARDINAL HEALTH 200, LLC NOVA PLUS; INFANT HEEL WARMER (CHEMICAL HEAT PACK)

Catalog Number	V11460-010
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	03/17/2026
Type of Reportable Event	Malfunction
Event or Problem Description
Instant infant heel warmer packet - went cold rather than warm when activated per instructions.

• Brand Name: NOVA PLUS
• Common Device Name: INFANT HEEL WARMER (CHEMICAL HEAT PACK)
• Manufacturer (Section D): CARDINAL HEALTH 200, LLC
• MDR Report Key: 24689201
• Report Number: MW5185836
• Device Sequence Number: 13377892
• Product Code: MPO
• UDI-Device Identifier: 10192253061468
• UDI-Public: (01)10192253061468
• Combination Product (Y/N): N
• Initial Reporter State: IN
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Voluntary
• Initial Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date (Section B): 03/17/2026

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 Catalogue Number: V11460-010
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 03/25/2026
• Patient Sequence Number: 1
• Patient Sex: Unknown