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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: CODMAN & SHURTLEFF, INC. CODMAN EDS 3 CSF EXTERNAL DRAINAGE SYSTEM WITH VENTRICULAR CATHETER

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CODMAN & SHURTLEFF, INC. CODMAN EDS 3 CSF EXTERNAL DRAINAGE SYSTEM WITH VENTRICULAR CATHETER Back to Search Results
Model Number 82-1730
Device Problem Device Operational Issue (2914)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 03/19/2018
Event Type  malfunction  
Event Description
As reported on an excel spreadsheet received from codman "an icp would not drain. The tubing was purged by suction at the proximal valve with a syringe. There were no reports of patient harm". Additional information has been requested.
 
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Brand NameCODMAN EDS 3 CSF EXTERNAL DRAINAGE SYSTEM WITH VENTRICULAR CATHETER
Type of DeviceEXTERNAL DRAINAGE SYSTEM
Manufacturer (Section D)
CODMAN & SHURTLEFF, INC.
325 paramount drive
raynham MA 02767
Manufacturer (Section G)
CODMAN & SHURTLEFF, INC.
328 paramount drive
raynham MA 02767
Manufacturer Contact
martin dockter
5955 pacific center blvd
san diego, CA 92121
8584551115
MDR Report Key7480787
MDR Text Key107756225
Report Number2023988-2018-00017
Device Sequence Number1
Product Code JXG
Combination Product (y/n)N
Reporter Country CodeFR
PMA/PMN Number
K162437
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type distributor,foreign,user faci
Reporter Occupation
Remedial Action Other
Type of Report Initial,Followup,Followup
Report Date 05/02/2018
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received05/02/2018
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Other Health Care Professional
Device Model Number82-1730
Device Catalogue Number821730
Was Device Available for Evaluation? No Answer Provided
Is the Reporter a Health Professional? No
Was the Report Sent to FDA? No
Event Location No Information
Date Manufacturer Received04/02/2018
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device?
Type of Device Usage

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