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

Catalog Number V11443-012B

Device Problem Material Rupture (1546)

Patient Problems Erythema (1840); Irritation (1941)

Event Date 02/05/2020

Event Type  malfunction  

Event Description

Add'l info received from reporter on 02/20/2020."hot pack ruptured when staff member attempted to activate by squeezing.The content caused redness and mild irritation to staff member's arm.A second hot pack ruptured during the same shift involving a different staff member.No harm to pt.".

• Brand Name: NOVAPLUS INSTANT HOT PACK
• Type of Device: PACK, HOT OR COLD, DISPOSABLE
• Manufacturer (Section D): CARDINAL HEALTH ; dublin OH 43017
• MDR Report Key: 9739732
• MDR Text Key: 180852738
• Report Number: MW5093179
• 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: 02/07/2020

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: V11443-012B
• Device Lot Number: V9S079
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 02/20/2020
• 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