MAUDE Adverse Event Report: MEDLINE MEDLINE; INSTANT HOT PACK

Lot Number	VN20010
Health Effect - Clinical Code	Chemical Exposure (2570)
Date of Event	09/17/2020
Type of Reportable Event	Malfunction
Event or Problem Description
Rn popped hot pack to apply to forearm to prepare vein and hot pack opened up and spilt on patient.Patient was not injured in event.

• Brand Name: MEDLINE
• Common Device Name: INSTANT HOT PACK
• Manufacturer (Section D): MEDLINE; one medline pl.; mundelein IL 60060
• MDR Report Key: 10746990
• Report Number: 10746990
• Device Sequence Number: 4123719
• Product Code: IMD
• UDI-Device Identifier: 10888277320543
• UDI-Public: (01)10888277320543
• Combination Product (Y/N): N
• Initial Reporter State: RI
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: User Facility
• Initial Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date (Section B): 10/07/2020
• Report Date (Section F): 10/07/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Lot Number: VN20010
• Was the Report Sent to FDA?: Yes
• Event Location: Hospital
• Date Report to Manufacturer: 10/28/2020
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 10/28/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Date Report Sent to FDA: 10/07/2020