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

Device Problem Burst Container or Vessel (1074)

Patient Problem Exposure to Body Fluids (1745)

Event Date 01/03/2020

Event Type  Injury  

Event Description

Two instances of novaplus instant hot packs exploding during attempts to activate.Contents from one of the hot packs struck an employee in the face, requiring eye irrigation in the emergency room.There is one add'l number on the hot pack, (b)(4).It is also important to note that one of the hot packs was thrown away.Therefore, we are not able to confirm whether both hot packs came from the same lot.

• Brand Name: NOVAPLUS INSTANT HOT PACK
• Type of Device: PACK, HOT OR COLD, DISPOSABLE
• Manufacturer (Section D): CARDINAL HEALTH 200, LLC ; waukegan IL
• MDR Report Key: 9601648
• MDR Text Key: 176012742
• Report Number: MW5092343
• Device Sequence Number: 2
• Product Code: IMD
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 01/07/2020
• 2 Devices were Involved in the Event: 1 2

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 01/16/2020
• Was Device Evaluated by Manufacturer?: No Information
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention