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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: CARDINAL HEALTH; INFANT HEEL WARMER

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CARDINAL HEALTH; INFANT HEEL WARMER Back to Search Results
Model Number 11470-01-01
Device Problem Fluid/Blood Leak (1250)
Patient Problem No Information (3190)
Event Date 09/18/2017
Event Type  malfunction  
Event Description
Heel warmer solution leaked out of package after activation.
 
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Type of Device
INFANT HEEL WARMER
Manufacturer (Section D)
CARDINAL HEALTH
1500 waukegan rd
waukegan IL 60085
MDR Report Key6939991
MDR Text Key88951953
Report Number6939991
Device Sequence Number1
Product Code MPO
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source User Facility
Reporter Occupation Other
Type of Report Initial
Report Date 10/05/2017
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator No Information
Device Expiration Date12/01/2019
Device Model Number11470-01-01
Device Catalogue Number11470-01-01
Was Device Available for Evaluation? No
Was the Report Sent to FDA? Yes
Date Report Sent to FDA10/05/2017
Device Age1 DY
Event Location Hospital
Date Report to Manufacturer10/05/2017
Initial Date Manufacturer Received Not provided
Initial Date FDA Received10/11/2017
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage N
Patient Sequence Number1
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