MAUDE Adverse Event Report: CARDINAL HEALTH 200, LLC NOVAPLUS; PACK, HOT OR COLD, DISPOSABLE

Model Number	V11440-512
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/22/2025
Type of Reportable Event	Malfunction
Event or Problem Description
Was activating a hot pack (hot pack compress chaude 4.5 x 9 in) for a patient to use when the top completely broke open and the internal contents were expelled approximately 8 feet in front of nurse, towards the patient.

• Brand Name: NOVAPLUS
• Common Device Name: PACK, HOT OR COLD, DISPOSABLE
• Manufacturer (Section D): CARDINAL HEALTH 200, LLC; 3651 birchwood drive; waukegan IL 60085
• MDR Report Key: 22838341
• Report Number: 22838341
• Device Sequence Number: 21184765
• Product Code: IMD
• UDI-Device Identifier: 10192253061451
• UDI-Public: (01)10192253061451
• Combination Product (Y/N): N
• Initial Reporter State: WI
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 08/07/2025
• Report Date (Section F): 08/07/2025

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 Model Number: V11440-512
• Device Catalogue Number: V11440-512
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Event Location: Hospital
• Date Report to Manufacturer: 08/19/2025
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 08/19/2025
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Patient Sex: Unknown
• Date Report Sent to FDA: 08/07/2025