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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: CARDINAL HEALTH 200, LLC NOVAPLUS HOT PACK INSTANT (6 IN. X 9 IN.) LARGE; PACK, HOT OR COLD, DISPOSABLE
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CARDINAL HEALTH 200, LLC NOVAPLUS HOT PACK INSTANT (6 IN. X 9 IN.) LARGE; PACK, HOT OR COLD, DISPOSABLE Back to Search Results
Model Number V11443-012B
Device Problems Noise, Audible (3273); Explosion (4006)
Patient Problem Burning Sensation (2146)
Event Date 07/25/2021
Event Type  malfunction  
Event Description
A lab team member went to draw a patient and had their supplies out, which included an adult heat pack.The rn came in and needed assistance in adjusting the patient so the lab team member moved the phlebotomy supplies to the cart and helped the rn.When the lab team member turned back to gather their supplies there was a pop (of which the rn heard as well) and then the pack exploded sending the inside liquid of the hot pack onto the lab team member's hand, sleeve of lab coat, floor and on the bed.The team member involved reported not activating the hot pack but hearing a popping sound just prior to the pack bursting.The team member experienced a burning sensation, but fortunately there was no injury to the staff members or patient.
 
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Brand Name
NOVAPLUS HOT PACK INSTANT (6 IN. X 9 IN.) LARGE
Type of Device
PACK, HOT OR COLD, DISPOSABLE
Manufacturer (Section D)
CARDINAL HEALTH 200, LLC
3651 birchwood drive
waukegan IL 60085
MDR Report Key12306521
MDR Text Key265994893
Report Number12306521
Device Sequence Number1
Product Code IMD
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source User Facility
Reporter Occupation Other Health Care Professional
Type of Report Initial
Report Date 08/02/2021,07/29/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received08/11/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator No Information
Device Model NumberV11443-012B
Device Catalogue NumberV11443-012B
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? Yes
Date Report Sent to FDA08/02/2021
Event Location Hospital
Date Report to Manufacturer08/11/2021
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Unknown
Patient Sequence Number1
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