MAUDE Adverse Event Report: CARDINAL HEALTH 200, LLC INFANT HEEL WARMER; INFANT HEEL WARMER (CHEMICAL HEAT PACK)

Model Number 11470-010T

Device Problems Leak/Splash (1354); Material Rupture (1546)

Patient Problem Foreign Body In Patient (2687)

Event Date 07/02/2017

Event Type  malfunction  

Event Description

A heel warmer was activated and wrapped around infant's foot.The heel warmer ruptured emitting a green substance onto the patient.

• Brand Name: INFANT HEEL WARMER
• Type of Device: INFANT HEEL WARMER (CHEMICAL HEAT PACK)
• Manufacturer (Section D): CARDINAL HEALTH 200, LLC; 1500 waukegan rd; waukegan IL 60085
• MDR Report Key: 6773428
• MDR Text Key: 82040138
• Report Number: 6773428
• Device Sequence Number: 1
• Product Code: MPO
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 07/18/2017

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: No Information
• Device Expiration Date: 08/27/2019
• Device Model Number: 11470-010T
• Other Device ID Number: 0110885380044847
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 07/18/2017
• Device Age: 1 DY
• Event Location: Hospital
• Date Report to Manufacturer: 07/18/2017
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 08/08/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1