MAUDE Adverse Event Report: MEDLINE MEDLINE; INSTANT HOT PACK

Lot Number VN20010

Device Problems Leak/Splash (1354); Material Split, Cut or Torn (4008)

Patient Problem Chemical Exposure (2570)

Event Date 09/17/2020

Event Type  malfunction  

Event 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
• Type of Device: INSTANT HOT PACK
• Manufacturer (Section D): MEDLINE; one medline pl.; mundelein IL 60060
• MDR Report Key: 10746990
• MDR Text Key: 213431367
• Report Number: 10746990
• Device Sequence Number: 1
• Product Code: IMD
• UDI-Device Identifier: 10888277320543
• UDI-Public: (01)10888277320543
• 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: 10/07/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/28/2020
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Lot Number: VN20010
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 10/07/2020
• Event Location: Hospital
• Date Report to Manufacturer: 10/28/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Age: 23360 DA