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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: CARDINAL HEALTH 200, LLC CARDINAL HEALTH; PACK, HOT OR COLD, DISPOSABLE
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CARDINAL HEALTH 200, LLC CARDINAL HEALTH; PACK, HOT OR COLD, DISPOSABLE Back to Search Results
Model Number 11450-040
Device Problems Premature Activation (1484); Defective Device (2588)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 07/12/2023
Event Type  malfunction  
Event Description
324 defective cardinal hot packs out of the 400 that were purchased for use in couplet care were found to be defective as the chemical packs were hard and previously activated, and could no longer be used.Therefore, the manufacturer was contacted and the defective hot packs were returned.
 
Event Description
324 defective cardinal hot packs out of the 400 that were purchased for use in couplet care were found to be defective as the chemical packs were hard and previously activated, and could no longer be used.Therefore, the manufacturer was contacted and the defective hot packs were returned.
 
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Brand Name
CARDINAL HEALTH
Type of Device
PACK, HOT OR COLD, DISPOSABLE
Manufacturer (Section D)
CARDINAL HEALTH 200, LLC
3651 birchwood drive
waukegan IL 60085
MDR Report Key17395756
MDR Text Key319756673
Report Number17395756
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,Followup
Report Date 07/21/2023
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received07/26/2023
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model Number11450-040
Device Catalogue Number11450-040B
Device Lot NumberV3C196
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer07/20/2023
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? Yes
Date Report Sent to FDA07/21/2023
Device Age0 YR
Event Location Hospital
Date Report to Manufacturer07/26/2023
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Unknown
Patient Sequence Number1
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