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

Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	01/11/2019
Type of Reportable Event	Malfunction
Event or Problem Description
Heel warmer placed on infant's foot.Package broke/exploded onto infant's foot, bedding and crib.

• Brand Name: INFANT HEEL WARMER
• Common Device Name: INFANT HEEL WARMER (CHEMICAL HEAT PACK)
• Manufacturer (Section D): CARDINAL HEALTH 200, LLC.; waukegan IL 60085
• MDR Report Key: 8253099
• Report Number: MW5083140
• Device Sequence Number: 2056243
• Product Code: MPO
• UDI-Device Identifier: 10885380044847
• UDI-Public: (01)10885380044847
• Combination Product (Y/N): N
• Initial Reporter State: MO
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Voluntary
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 01/14/2019

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
• Operator of Device: Health Professional
• Device Expiration Date: 09/10/2020
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 01/15/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 1 DA
• Patient Weight: 3