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

Catalog Number 11460-010T

Patient Problem Chemical Exposure (2570)

Event Date 01/02/2024

Event Type  Injury  

Event Description

Registered nurse squeezed the infant heel warmer to activate it and the package busted open and a large amount of liquid exploded into the registered nurse's eye registered nurse was taken immediately to the eyewash station (stayed for 15min).House supervisor was called immediately and the rapid response registered nurse came to the unit to transport the registered nurse to the emergency room via wheelchair.The registered nurse was using the heel warmer as per manufactures instructions.Unclear why it ruptured.Registered nurse to the eye wash station, flushed her eyes for several minutes.Rapid response took registered nurse to emergency department for follow up.Registered nurse discharged home with family and follow up visit with employee health and eye specialist.

• Brand Name: CARDINAL HEALTH INFANT HEEL WARMER
• Type of Device: INFANT HEEL WARMER (CHEMICAL HEAT PACK)
• Manufacturer (Section D): CARDINAL HEALTH 200, LLC.
• MDR Report Key: 18858086
• MDR Text Key: 337358276
• Report Number: MW5152458
• Device Sequence Number: 1
• Product Code: MPO
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 03/04/2024

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: Health Professional
• Device Catalogue Number: 11460-010T
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 03/06/2024
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 61 YR
• Patient Sex: Female
• Patient Weight: 89 KG