MAUDE Adverse Event Report: CARDINAL HEALTH 200, LLC TINY TOES INFANT HEEL WARMER; PACK, HOT OR COLD, DISPOSABLE

Model Number 11470-010T

Device Problem Overheating of Device (1437)

Patient Problem No Information (3190)

Event Date 08/13/2018

Event Type  malfunction  

Event Description

Lab tech went in to draw baby on 6th floor, ran out of heel warmers.Rn provided one, when activated the warmer, discovered the temp was really hot, it could have burned the baby.Lot# 011314 cardinal health (tiny toes infant heel warmer).

• Brand Name: TINY TOES INFANT HEEL WARMER
• Type of Device: PACK, HOT OR COLD, DISPOSABLE
• Manufacturer (Section D): CARDINAL HEALTH 200, LLC; 808 w highway 24; moberly MO 65270
• MDR Report Key: 7822169
• MDR Text Key: 118404474
• Report Number: 7822169
• Device Sequence Number: 1
• Product Code: IMD
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 08/15/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 11470-010T
• Device Catalogue Number: 11470-010T
• Device Lot Number: 011314
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 08/15/2018
• Event Location: Hospital
• Date Report to Manufacturer: 08/28/2018
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 08/28/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1