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

Catalog Number MDS139009

Device Problem Fluid/Blood Leak (1250)

Patient Problem Chemical Exposure (2570)

Event Date 01/29/2022

Event Type  malfunction  

Event Description

The medline large hot pack leaked onto the patient's abdomen while in use.A white residue was observed on the patient's skin and clothing.The skin appeared intact without redness.Upon speaking to other nurses, there has been at least three prior incidents.

• Brand Name: INSTANT HOT PACK
• Type of Device: PACK, HOT OR COLD, DISPOSABLE
• Manufacturer (Section D): MEDLINE INDUSTRIES, INC.; one medline pl; mundelein IL 60060
• MDR Report Key: 13513877
• MDR Text Key: 285472909
• Report Number: 13513877
• 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: Risk Manager
• Type of Report: Initial
• Report Date: 01/31/2022

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 Catalogue Number: MDS139009
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 01/31/2022
• Event Location: Hospital
• Date Report to Manufacturer: 02/11/2022
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 02/11/2022
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1