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

Catalog Number V11450-040B

Patient Problems Partial thickness (Second Degree) Burn (2694); Blister (4537)

Event Date 11/08/2023

Event Type  malfunction  

Event Description

Novaplus instant hot pack item# v11450-040b manufactured by cardinal health burst open when the registered nurse attempted to activate the pack by squeezing it.Contents splashed on to the nurse's neck, chest and wrist and immediately became hot.The nurse sustained second-degree burns with blistering and open skin.

• Brand Name: CARDINAL HEALTH NOVAPLUS INSTANT HOT PACK
• Type of Device: PACK, HOT OR COLD, DISPOSABLE
• Manufacturer (Section D): CARDINAL HEALTH 200, LLC.
• MDR Report Key: 18191926
• MDR Text Key: 328959329
• Report Number: MW5148367
• Device Sequence Number: 1
• 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: 11/17/2023

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
• Device Operator: Health Professional
• Device Catalogue Number: V11450-040B
• Device Lot Number: VN23130-2526
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 11/21/2023
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other