MAUDE Adverse Event Report: MEDLINE INDUSTRIES, INC. INSTANT HOT PACK; PACK, HOT OR COLD, DISPOSABLE

Device Problems Gel Leak (1267); Explosion (4006)

Patient Problem Chemical Exposure (2570)

Event Date 12/14/2019

Event Type  malfunction  

Event Description

Father of patient attempted to "crack" an instant heat pack for the patient and the heat pack exploded and covered his hands with the gel from the inside.

• Brand Name: INSTANT HOT PACK
• Type of Device: PACK, HOT OR COLD, DISPOSABLE
• Manufacturer (Section D): MEDLINE INDUSTRIES, INC.; three lakes drive; northfield IL 60093
• MDR Report Key: 9659304
• MDR Text Key: 177371728
• Report Number: 9659304
• 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: Other Health Care Professional
• Type of Report: Initial
• Report Date: 12/19/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• 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: 12/19/2019
• Event Location: Hospital
• Date Report to Manufacturer: 02/03/2020
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 02/03/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1