MAUDE Adverse Event Report: CARDINAL HEALTH HOT PACK INSULATED INSTANT; A HOT PACK, ACTUATED BY CRUSHING THE PACKET

Device Problems Device Slipped (1584); Use of Device Problem (1670)

Patient Problem Full thickness (Third Degree) Burn (2696)

Event Date 12/31/2017

Event Type  Injury  

Event Description

A pt used a hot pack, mfr - cardinal health, hot pack insulated instant.She fell asleep, the hot pack slid from her chest.It resulted in a small full thickness (third degree) burn to the left breast.(b)(6).(b)(4).

• Brand Name: HOT PACK INSULATED INSTANT
• Type of Device: A HOT PACK, ACTUATED BY CRUSHING THE PACKET
• Manufacturer (Section D): CARDINAL HEALTH
• MDR Report Key: 7269945
• MDR Text Key: 100058703
• Report Number: MW5075232
• 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: Other Health Care Professional
• Type of Report: Initial
• Report Date: 01/09/2018

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: No Information
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 02/14/2018
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 51 YR