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

Lot Number VN22182

Device Problem Patient Device Interaction Problem (4001)

Patient Problems Pyrosis/Heartburn (1883); Skin Inflammation/ Irritation (4545)

Event Date 01/18/2023

Event Type  malfunction  

Event Description

Patient was found with an opened hot pack in his mouth.Staff were unsure if the patient ingested any of the contents.The provider was notified and poison control was called.Poison control advised to have patient swish and spit x3.No contents were found in the patients mouth.Patient has slight stomach and mouth irritation, but no permanent harm.

• Brand Name: INSTANT HOT PACK
• Type of Device: PACK, HOT OR COLD, DISPOSABLE
• Manufacturer (Section D): MEDLINE INDUSTRIES; one medline place; mundelein IL 60060
• MDR Report Key: 16467233
• MDR Text Key: 310524929
• Report Number: 16467233
• 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: 01/31/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/02/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Lot Number: VN22182
• 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: 01/31/2023
• Event Location: Hospital
• Date Report to Manufacturer: 03/02/2023
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 26645 DA
• Patient Sex: Male
• Patient Weight: 66 KG
• Patient Race: Black Or African American