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

Lot Number VN23217

Patient Problems Burning Sensation (2146); Chemical Exposure (2570)

Event Date 01/14/2024

Event Type  malfunction  

Event Description

Staff member utilized the cold compress and placed it on his forehead.He then felt a burning sensation on his left eyelid and left side of the face.It appeared that the cold pack leaked.The staff declined medical intervention and reported relief before shift ended.Investigation is ongoing and the staff is currently not available to provide clarification on how the cold compress was activated.The compress was discarded.The device information provided to this report is based on the remaining supply in the unit.

• Brand Name: MEDLINE INSTANT DELUXE COLD PACK
• Type of Device: PACK, HOT OR COLD, DISPOSABLE
• Manufacturer (Section D): MEDLINE INDUSTRIES, LP - NORTHFIELD; northfield IL 60093
• MDR Report Key: 18563855
• MDR Text Key: 333601725
• Report Number: MW5150634
• 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: Risk Manager
• Type of Report: Initial
• Report Date: 01/18/2024

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: VN23217
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 01/22/2024
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Sex: Male