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

Catalog Number 11470-010T

Device Problem Leak/Splash (1354)

Patient Problem Chemical Exposure (2570)

Event Date 08/29/2017

Event Type  malfunction  

Event Description

Cardinal health infant heel warmer leaked at the seam; contents of warmer has made contact with pt and pt's family.

• Brand Name: TINY TOES INFANT HEEL WARMER
• Type of Device: HEEL INFANT WARMER
• Manufacturer (Section D): CARDINAL HEALTH; montgomery NY 12549
• MDR Report Key: 6861460
• MDR Text Key: 85946858
• Report Number: MW5072109
• 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: Other Health Care Professional
• Type of Report: Initial
• Report Date: 09/11/2017

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: 11470-010T
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/04/2017
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 09/13/2017
• Was Device Evaluated by Manufacturer?: No Information
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1