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

Catalog Number 11470-010T

Device Problem Overheating of Device (1437)

Patient Problem No Patient Involvement (2645)

Event Date 04/28/2015

Event Type  malfunction  

Event Description

When nurse was activating a heel warmer, she noted it became hot which could potentially cause skin damage to an infant.When she tested the warmer, it was 108 degrees fahrenheit, which is three degrees over the recommended 105 degrees.

• Brand Name: TINY TOES INFANT HEEL WARMER
• Type of Device: INFANT HEEL WARMER (CHEMICAL HEAT PACK)
• Manufacturer (Section D): CARDINAL HEALTH 200, LLC; 808 west highway 24; moberly MO 65270
• MDR Report Key: 4741634
• MDR Text Key: 5821431
• Report Number: 4741634
• Device Sequence Number: 1
• Product Code: MPO
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Invalid Data
• Type of Report: Initial
• Report Date: 04/30/2015

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: Nurse
• Device Catalogue Number: 11470-010T
• Device Lot Number: 041108
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 04/30/2015
• Event Location: Hospital
• Date Report to Manufacturer: 05/01/2015
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 04/30/2015
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: NO, INCIDENT DID NOT REACH THE PATIENT.