MAUDE Adverse Event Report: CARDINAL HEALTH 200, LLC NOVAPLUS INSTANT HOT PACK; PACK, HOT OR COLD, DISPOSABLE

Model Number V11443-012B

Device Problem Material Rupture (1546)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 03/24/2020

Event Type  malfunction  

Event Description

Rn was popping hot pack for patient.It popped easily but then ruptured and got on the patient's face, hair, gown, bed and floor, and on the rn's hands and scrubs.Pt cleaned up, bed changed & floor wiped up.No burning sensation or injury noted or reported.

• Brand Name: NOVAPLUS INSTANT HOT PACK
• Type of Device: PACK, HOT OR COLD, DISPOSABLE
• Manufacturer (Section D): CARDINAL HEALTH 200, LLC; 3651 birchwood drive; waukegan IL 60085
• MDR Report Key: 9897218
• MDR Text Key: 185506183
• Report Number: 9897218
• 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: Nurse
• Type of Report: Initial
• Report Date: 03/24/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: V11443-012B
• Device Catalogue Number: V11443-012B
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 03/24/2020
• Event Location: Hospital
• Date Report to Manufacturer: 03/30/2020
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 03/30/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 11680 DA
• Patient Weight: 121