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

Catalog Number 11470-010T

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Burn(s) (1757)

Event Date 04/28/2017

Event Type  Injury  

Event 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
• Type of Device: HEEL WARMER WITH DISC ACTIVATION
• Manufacturer (Section D): CARDINAL HEALTH; waukegan IL 60085
• MDR Report Key: 6568707
• MDR Text Key: 75322281
• Report Number: MW5069796
• Device Sequence Number: 1
• Product Code: MPO
• UDI-Device Identifier: 10885380044847
• UDI-Public: 0110885380044847
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 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
• Device Operator: No Information
• Device Expiration Date: 08/27/2019
• Device Catalogue Number: 11470-010T
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 05/12/2017
• Was Device Evaluated by Manufacturer?: No Information
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention