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

Catalog Number REF MH00002T

Device Problem Burst Container or Vessel (1074)

Patient Problem Chemical Exposure (2570)

Event Date 12/23/2020

Event Type  Injury  

Event Description

Infant heel warmer exploded in associate's face when trying to activate.Fda safety report id # (b)(4).

• Brand Name: ARGYLE (COVIDIEN)
• Type of Device: INFANT HEEL WARMER (CHEMICAL HEAT PACK)
• Manufacturer (Section D): COVIDIEN/ CARDINAL HEALTH
• MDR Report Key: 11147343
• MDR Text Key: 226334393
• Report Number: MW5098749
• Device Sequence Number: 1
• Product Code: MPO
• Combination Product (y/n): Y
• 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: 01/07/2021

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: REF MH00002T
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 01/08/2021
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention