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

Catalog Number V11443-012B

Device Problem Explosion (4006)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 02/09/2020

Event Type  malfunction  

Event Description

Hot pack exploded when staff member attempted to activate.Contents of hot pack made contact with clothing of two staff members.No staff or pt harm.

• Brand Name: NOVAPLUS INSTANT HOT PACK
• Type of Device: PACK, HOT OR COLD, DISPOSABLE
• Manufacturer (Section D): CARDINAL HEALTH 200, LLC
• MDR Report Key: 9750346
• MDR Text Key: 181136285
• Report Number: MW5093233
• 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: Risk Manager
• Type of Report: Initial
• Report Date: 02/10/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: V11443-012B
• Device Lot Number: V0A101
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 02/24/2020
• 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