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

Model Number 11460-010T

Device Problems Material Rupture (1546); Unexpected Therapeutic Results (1631)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 06/22/2022

Event Type  Injury  

Event Description

During the admission of a baby to the special care nursery a heel warmer was obtained.When squeezing the heel warmer to activate it to place on patient, the warmer exploded in my hand which caused the content inside to spray across room.The content came into contact and landed on baby and another nurse.Baby cleaned immediately with soap and water.Skin was assessed no evidence noted of any reaction or redness.Nnp was notified and continued to monitor baby.Fda safety report id# (b)(4).

• Brand Name: CARDINAL INFANT HEEL WARMER
• Type of Device: INFANT HEEL WARMER (CHEMICAL HEAT PACK)
• Manufacturer (Section D): CARDINAL HEALTH 200, LLC
• MDR Report Key: 15067032
• MDR Text Key: 296324541
• Report Number: MW5110974
• 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: Nurse
• Type of Report: Initial
• Report Date: 07/15/2022

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?: Yes
• Device Operator: Health Professional
• Device Model Number: 11460-010T
• Device Catalogue Number: 11460-010T
• Device Lot Number: V2C235
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 07/19/2022
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention