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

Catalog Number 11470-010T

Device Problem Explosion (4006)

Patient Problem Insufficient Information (4580)

Event Date 05/27/2021

Event Type  malfunction  

Event Description

Cardinal health infant heel warmers (2) exploded during activation.Green contents went on user's skin, clothing and surrounding area.

• Brand Name: CARDINAL HEALTH INFANT HEEL WARMER
• Type of Device: INFANT HEEL WARMER (CHEMICAL HEAT PACK)
• Manufacturer (Section D): CARDINAL HEALTH
• MDR Report Key: 11999042
• MDR Text Key: 256525025
• Report Number: MW5101885
• Device Sequence Number: 2
• Product Code: MPO
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 06/10/2021
• 2 Devices were Involved in the Event: 1 2

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: 10/18/2022
• 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: 06/14/2021
• 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