MAUDE Adverse Event Report: MCKESSON MEDICAL SURGICAL INC. INSTANT HOT PACK MCKESSON GENERAL PURPOSE LARGE; PACK, HOT OR COLD, DISPOSABLE

Model Number 16-9707

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Erythema (1840); Partial thickness (Second Degree) Burn (2694); Blister (4537)

Event Date 01/22/2022

Event Type  Injury  

Event Description

Newborn infant hypothermic at birth.Admitted to nicu.Heat pack placed on right foot to dilate vein for iv start.Product placed directly to foot.Between 1-2 minutes of time, blisters occurred on the right foot on (3) surfaces: foot, ankle and heel surrounded by erythema.Md and wound team notified.Patient is being followed by plastics.Burns to right foot are superficial and deep thickness.Total body surface area (tbsa) 1%.Burn wounds demonstrating signs of healing on current wound regimen.Fda safety report id (b)(4).

• Brand Name: INSTANT HOT PACK MCKESSON GENERAL PURPOSE LARGE
• Type of Device: PACK, HOT OR COLD, DISPOSABLE
• Manufacturer (Section D): MCKESSON MEDICAL SURGICAL INC.; 6555 state hwy 161; irving TX 75039
• MDR Report Key: 13499912
• MDR Text Key: 285413201
• Report Number: MW5107317
• Device Sequence Number: 1
• Product Code: IMD
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 02/04/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 16-9707
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 02/08/2022
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Sex: Male
• Patient Weight: 3 KG
• Patient Ethnicity: Hispanic
• Patient Race: White