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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: CODMAN & SHURTLEFF, INC BACTISEAL CLEAR EVD CATHETER SHUNT, CENTRAL NERVOUS SYSTEM

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CODMAN & SHURTLEFF, INC BACTISEAL CLEAR EVD CATHETER SHUNT, CENTRAL NERVOUS SYSTEM Back to Search Results
Catalog Number 82-1750
Device Problem Fracture (1260)
Patient Problem Swelling (2091)
Event Date 07/05/2016
Event Type  malfunction  
Event Description
During craniotomy, a evd was placed. The patient had swelling on the right side of face following surgery. After it was removed by the neurosurgeon, he found it to be fractured.
 
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Brand NameBACTISEAL CLEAR EVD CATHETER
Type of DeviceSHUNT, CENTRAL NERVOUS SYSTEM
Manufacturer (Section D)
CODMAN & SHURTLEFF, INC
325 paramount drive
raynham, MA 02767
MDR Report Key5839412
MDR Text Key50914958
Report Number5839412
Device Sequence Number1
Product Code JXG
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source User Facility
Reporter Occupation
Type of Report Initial
Report Date 07/19/2016,07/21/2016
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received08/02/2016
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date03/31/2017
Device Catalogue Number82-1750
Device Lot NumberC14289
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? Yes
Date Report Sent to FDA07/19/2016
Device Age1 DY
Event Location Hospital
Date Report to Manufacturer07/19/2016
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is the Device Single Use? No Answer Provided
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage

Patient Treatment Data
Date Received: 08/02/2016 Patient Sequence Number: 1
Treatment
PATIENT WAS HAVING A CRANIOTOMY. THERE ARE MANY IN
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