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

Lot Number VN22361-78

Patient Problem Chemical Exposure (2570)

Event Date 06/26/2023

Event Type  malfunction  

Event Description

Employee went to squeeze hot pack to activate.Hot pack burst, covering employee in the fluid from the pack.

• Brand Name: CARDINAL HEALTH INSULATED INSTANT HOT PACK
• Type of Device: PACK, HOT OR COLD, DISPOSABLE
• Manufacturer (Section D): CARDINAL HEALTH 200, LLC; 3651 birchwood drive; waukegan IL 60085
• MDR Report Key: 17375760
• MDR Text Key: 319573641
• Report Number: 17375760
• Device Sequence Number: 1
• Product Code: IMD
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 06/30/2023

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: Other
• Device Lot Number: VN22361-78
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 06/30/2023
• Event Location: Hospital
• Date Report to Manufacturer: 07/24/2023
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 07/24/2023
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1