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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: CARDINAL HEALTH 200, LLC PRESOURCE CRANIOTOMY CUSTOM PACK; NEUROLOGICAL TRAY
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CARDINAL HEALTH 200, LLC PRESOURCE CRANIOTOMY CUSTOM PACK; NEUROLOGICAL TRAY Back to Search Results
Model Number SNE23CR525
Device Problem Packaging Problem (3007)
Patient Problem Insufficient Information (4580)
Event Date 06/16/2021
Event Type  malfunction  
Event Description
Craniotomy pack had 1 additional pack of 1x1 neuro patties.
 
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Brand Name
PRESOURCE CRANIOTOMY CUSTOM PACK
Type of Device
NEUROLOGICAL TRAY
Manufacturer (Section D)
CARDINAL HEALTH 200, LLC
3651 birchwood drive
waukegan IL 60085
MDR Report Key12099455
MDR Text Key259447087
Report Number12099455
Device Sequence Number1
Product Code OJG
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source User Facility
Reporter Occupation Administrator/Supervisor
Type of Report Initial
Report Date 06/22/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received07/01/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model NumberSNE23CR525
Device Catalogue NumberSNE23CR525
Device Lot Number582465
Was the Report Sent to FDA? Yes
Date Report Sent to FDA06/22/2021
Event Location Hospital
Date Report to Manufacturer07/01/2021
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Unknown
Patient Sequence Number1
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