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

Model Number 11445-020

Device Problem Burst Container or Vessel (1074)

Patient Problem Chemical Exposure (2570)

Event Date 06/10/2014

Event Type  malfunction  

Event Description

The nurse activated a cold pack to give to patient for his ankle pain.She was unable to make the cold pack "pop" to activate so she passed it to a pca that was standing in front of the patient.When he squeezed the pack to activate it burst onto the patient and into his eye.

• Type of Device: COLD PACK
• Manufacturer (Section D): CARDINAL HEALTH 200, LLC; 1500 waukegan road; waukegan IL 60085
• MDR Report Key: 3983112
• MDR Text Key: 15106326
• Report Number: 3983112
• 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: 07/17/2014

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: Invalid Data
• Device Model Number: 11445-020
• Device Lot Number: V4E173
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 07/17/2014
• Event Location: Hospital
• Date Report to Manufacturer: 08/06/2014
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 07/17/2014
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1