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

Catalog Number 11460-010T

Device Problems Patient-Device Incompatibility (2682); Device Operates Differently Than Expected (2913)

Patient Problem Burn(s) (1757)

Event Date 03/09/2017

Event Type  malfunction  

Event Description

Infant heel warmer pack was activated and placed on patient arm for blood draw.Burn was found on skin later and could not rule out warmer pack definitively.

• Brand Name: INFANT HEEL WARMER
• Type of Device: INFANT HEEL WARMER (CHEMICAL HEAT PACK)
• Manufacturer (Section D): CARDINAL HEALTH 200, LLC.; 1500 waukegan rd.; waukegan IL 60085
• MDR Report Key: 6544526
• MDR Text Key: 74429987
• Report Number: 6544526
• 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: User Facility
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 04/25/2017

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: No Information
• Device Catalogue Number: 11460-010T
• Other Device ID Number: (01)10630140017391
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 04/25/2017
• Event Location: Hospital
• Date Report to Manufacturer: 04/25/2017
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 05/04/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 86 YR