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

Model Number 11460-010T

Device Problems Gel Leak (1267); Material Rupture (1546)

Patient Problem Chemical Exposure (2570)

Event Date 06/26/2023

Event Type  malfunction  

Event Description

From staff: employee went to get heel warmer initiated, burst and squirt employee in the face and all over chest and abdomen with harmful material.

• Brand Name: CARDINAL HEALTH
• Type of Device: INFANT HEEL WARMER (CHEMICAL HEAT PACK)
• Manufacturer (Section D): CARDINAL HEALTH 200, LLC; 3651 birchwood drive; waukegan IL 60085
• MDR Report Key: 17331812
• MDR Text Key: 319118814
• Report Number: 17331812
• Device Sequence Number: 1
• Product Code: MPO
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 06/27/2023

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 Model Number: 11460-010T
• Device Catalogue Number: 11460-010T
• Device Lot Number: V3B229 A
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 06/27/2023
• Event Location: Hospital
• Date Report to Manufacturer: 07/17/2023
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 07/17/2023
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Other