MAUDE Adverse Event Report: MEDLINE INDUSTRIES, LP - NORTHFIELD INSTANT HOT PACK; PACK, HOT OR COLD, DISPOSABLE

Lot Number VN22195

Device Problem Explosion (4006)

Patient Problems Eye Injury (1845); Chemical Exposure (2570)

Event Date 12/15/2022

Event Type  malfunction  

Event Description

As i attempted to activate a heat pack to give to the patient, it exploded in my hands covering both myself and the patient in the contents of the pack.It also got in both mine and the patient's eyes.

• Brand Name: INSTANT HOT PACK
• Type of Device: PACK, HOT OR COLD, DISPOSABLE
• Manufacturer (Section D): MEDLINE INDUSTRIES, LP - NORTHFIELD; three lakes drive; northfield IL 60093
• MDR Report Key: 16194472
• MDR Text Key: 307585459
• Report Number: 16194472
• Device Sequence Number: 1
• Product Code: IMD
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 12/19/2022

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 Operator: Health Professional
• Device Lot Number: VN22195
• 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: 12/19/2022
• Event Location: Hospital
• Date Report to Manufacturer: 01/18/2023
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 01/18/2023
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1