MAUDE Adverse Event Report: CARDINAL HEALTH CARDINAL HEALTH; INFANT HEEL WARMER

Lot Number 11460-010T

Device Problem Burst Container or Vessel (1074)

Patient Problems Itching Sensation (1943); Burning Sensation (2146)

Event Type  Injury  

Event Description

Nurse wanted to activate infant heel warmer.In trying to activate, it exploded splashing onto her hands and forearms.She has burning and itching to her forearms.She went to ed and ed physician sent her home for the rest of the day.

• Brand Name: CARDINAL HEALTH
• Type of Device: INFANT HEEL WARMER
• Manufacturer (Section D): CARDINAL HEALTH; brooklyn NY 11245
• MDR Report Key: 6450650
• MDR Text Key: 71613285
• Report Number: MW5068799
• Device Sequence Number: 1
• Product Code: MPO
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Other
• Type of Report: Initial

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 Lot Number: 11460-010T
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 03/29/2017
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention