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 No Known Impact Or Consequence To Patient (2692)

Event Date 03/14/2020

Event Type  malfunction  

Event Description

Heel warmer activated prior to lab on infant.Heel warmer exploded in rn's hands when compressed.

• Brand Name: ARGYLE
• Type of Device: INFANT HEEL WARMER (CHEMICAL HEAT PACK)
• Manufacturer (Section D): CARDINAL HEALTH, INC.; 15 hampshire street; mansfield MA 02048
• MDR Report Key: 10000695
• MDR Text Key: 189005238
• Report Number: 10000695
• 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: 03/16/2020

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: CH42SP41605
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 03/16/2020
• Event Location: Other
• Date Report to Manufacturer: 04/27/2020
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 04/27/2020
• Type of Device Usage: N
• Patient Sequence Number: 1