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

Device Problem Material Rupture (1546)

Patient Problem Chemical Exposure (2570)

Event Date 11/04/2022

Event Type  malfunction  

Event Description

As the healthcare worker was squeezing the hot pack to prepare it the hot pack burst open spilling the contents of the pack.The contents did come in contact with the healthcare worker.The packaging photos attached to this report are from a similar product, but not the exact package from the faulty product.We have no specific product details for the faulty product."ultimately we know only this.That the hot pack was from cardinial health." fda safety report id #(b)(4).

• Brand Name: HOT PACK INSTANT
• Type of Device: PACK, HOT OR COLD, DISPOSABLE
• Manufacturer (Section D): CARDINAL HEALTH
• MDR Report Key: 15825708
• MDR Text Key: 304131077
• Report Number: MW5113363
• 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: 11/15/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/17/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 73 YR
• Patient Sex: Male