MAUDE Adverse Event Report: CARDINAL HEALTH CARDINAL HEALTH INFANT HEEL WARMER; HEEL WARMER WITH DISC ACTIVATION

Catalog Number	11470-010T
Health Effect - Clinical Code	Burn(s) (1757)
Date of Event	04/28/2017
Type of Reportable Event	Serious Injury
Event or Problem Description
I burn area ~4x4cm outer red circle with 1x2cm inner circle dark blue was found on infant's left knee.This was treated with neosporin ointment.A heel warmer was found in the blankets but it is not known if the heel warmer directly caused this lesion.

• Brand Name: CARDINAL HEALTH INFANT HEEL WARMER
• Common Device Name: HEEL WARMER WITH DISC ACTIVATION
• Manufacturer (Section D): CARDINAL HEALTH; waukegan IL 60085
• MDR Report Key: 6568707
• Report Number: MW5069796
• Device Sequence Number: 13455735
• Product Code: MPO
• UDI-Device Identifier: 10885380044847
• UDI-Public: 0110885380044847
• Initial Reporter State: NY
• 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): 05/12/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: No Information
• Device Expiration Date: 08/27/2019
• Device Catalogue Number: 11470-010T
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 05/12/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention