MAUDE Adverse Event Report: CARDINAL HEALTH 200, LLC. 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

Two hot packs ruptured when attempting to activate by squeezing.Two separate staff members were involved.Neither used excessive force when squeezing to activate the pack.One staff member states little pressure was applied when the rupture occurred.There was no patient harm.One of the staff members experienced redness and mild irritation at a thumb.Fda safety report id # (b)(4).

• Brand Name: NOVAPLUS INSTANT HOT PACK
• Type of Device: PACK, HOT OR COLD, DISPOSABLE
• Manufacturer (Section D): CARDINAL HEALTH 200, LLC.
• MDR Report Key: 9693850
• MDR Text Key: 179105371
• Report Number: MW5092896
• 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
• 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: 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: 02/10/2020
• 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