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

Model Number MH00002T

Device Problem Burst Container or Vessel (1074)

Patient Problem Chemical Exposure (2570)

Event Date 04/06/2020

Event Type  malfunction  

Event Description

A heat pack was being activated.When squeezing heat pack, it exploded on me, my arm, scrubs, and face.Grabbed a second heat pack and the same thing happened with that one.Product from the heat pack covered me, the floor and a nearby wall and table.The first one i squeezed and the fourth one i squeezed activated as they should.

• Brand Name: ARGYLE
• Type of Device: INFANT HEEL WARMER (CHEMICAL HEAT PACK)
• Manufacturer (Section D): CARDINAL HEALTH, INC.; 15 hampshire st; mansfield MA 02048
• MDR Report Key: 10109802
• MDR Text Key: 193374423
• Report Number: 10109802
• 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: 04/23/2020

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: MH00002T
• Device Catalogue Number: MH00002T
• Device Lot Number: 005746X
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 04/23/2020
• Event Location: Other
• Date Report to Manufacturer: 06/02/2020
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 06/02/2020
• Type of Device Usage: N
• Patient Sequence Number: 1