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

Device Problems Leak/Splash (1354); Material Rupture (1546); Activation Problem (4042)

Patient Problem Chemical Exposure (2570)

Event Date 07/12/2022

Event Type  Injury  

Event Description

When activating warmer, the product broke open and contents made contact with patient's skin.Dose or amount: 1 an - as necessary, frequency: as needed, route: topical.

• Brand Name: INFANT HEEL WARMER
• Type of Device: INFANT HEEL WARMER (CHEMICAL HEAT PACK)
• Manufacturer (Section D): CARDINALHEALTH 200, LLC.
• MDR Report Key: 15067431
• MDR Text Key: 296341670
• Report Number: MW5110995
• Device Sequence Number: 1
• Product Code: MPO
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial
• Report Date: 07/18/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/19/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Sex: Female
• Patient Weight: 3 KG
• Patient Ethnicity: Hispanic
• Patient Race: White