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

Model Number 11443-012B

Device Problem Unintended Ejection (1234)

Patient Problem Chemical Exposure (2570)

Event Date 04/20/2021

Event Type  malfunction  

Event Description

Staff rn was trying to activate the heat pack.The chemicals got on her skin and clothing.No adverse effects reported.Did not come into contact with any patient.Manufacturer response for hot pack instant, (brand not provided) (per site reporter).Pending.

• Brand Name: CARDINAL HEALTH
• Type of Device: PACK, HOT OR COLD, DISPOSABLE
• Manufacturer (Section D): CARDINAL HEALTH 200, LLC; 3651 birchwood drive; waukegan IL 60085
• MDR Report Key: 11869649
• MDR Text Key: 252174711
• Report Number: 11869649
• 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: Risk Manager
• Type of Report: Initial
• Report Date: 05/18/2021,05/11/2021

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 Model Number: 11443-012B
• Device Catalogue Number: 11443-012B
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 05/18/2021
• Event Location: Hospital
• Date Report to Manufacturer: 05/24/2021
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 05/24/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1