MAUDE Adverse Event Report: CARDINAL HEALTH 200, LLC; HEAT PACK

Model Number 11443-512

Device Problem Burst Container or Vessel (1074)

Patient Problems Exposure to Body Fluids (1745); Burn, Thermal (2530)

Event Date 03/08/2015

Event Type  malfunction  

Event Description

Family member came to front desk and said to come to room right away.When we got to room patient's eyes were closed and there was a white substance on the patient and the walls.The patient said she squeezed her disposable heat pack to activate and it "exploded" in her face.We cleaned her face with water and the charge rn irrigated her eyes with normal saline.The doctor was paged and came to evaluate patient and called poison control.The house supervisor was also notified.Patient reported burning of eyes initially but resolved; patient without any signs of burns when physician examined patient.

• Type of Device: HEAT PACK
• Manufacturer (Section D): CARDINAL HEALTH 200, LLC; 1500 waukegan road; mcgaw park IL 60085
• MDR Report Key: 4608344
• MDR Text Key: 5633104
• Report Number: 4608344
• Device Sequence Number: 1
• Product Code: IMD
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 03/09/2015

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: Patient
• Device Model Number: 11443-512
• Device Lot Number: V5B181
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 03/09/2015
• Event Location: Hospital
• Date Report to Manufacturer: 03/17/2015
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 03/09/2015
• Patient Sequence Number: 1
• Patient Age: 58 YR
• Patient Weight: 78