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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

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CODMAN & SHURTLEFF, INC. CODMAN EDS 3 CSF EXTERNAL DRAINAGE SYSTEM Back to Search Results
Model Number 82-1731
Device Problem Device Operational Issue (2914)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 05/21/2018
Event Type  malfunction  
Event Description
Codman reported the following to natus on (b)(6) 2018: "as reported by the ous affiliate, an eds 3 will not drain csf form the collection chamber to the drip bag. Surgeon is continuously aspiring the chamber to reduce the csd collection while he waits for a replacement eds3. There were no reports of additional patient harm. " was the surgery delayed: no. Is this a revision of one or more implants: no. No reported patient or user harm. No further information was provided in relation to the patient. Additional information has been requested.
 
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Brand NameCODMAN EDS 3 CSF EXTERNAL DRAINAGE SYSTEM
Type of DeviceEXTERNAL DRAINAGE SYSTEM
Manufacturer (Section D)
CODMAN & SHURTLEFF, INC.
325 paramount drive
raynham MA 02767
Manufacturer (Section G)
CODMAN & SHURTLEFF, INC.
325 paramount drive
raynham MA 02767
Manufacturer Contact
martin dockter
5955 pacific center blvd.
san diego, CA 92121
8584551115
MDR Report Key7601305
MDR Text Key111163728
Report Number2023988-2018-00032
Device Sequence Number1
Product Code JXG
Combination Product (y/n)N
Reporter Country CodeSF
PMA/PMN Number
K162437
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type foreign,user facility
Reporter Occupation
Remedial Action Other
Type of Report Initial,Followup
Report Date 06/14/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received06/14/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Model Number82-1731
Device Catalogue Number821731
Device Lot Number136566
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
Was Device Evaluated by Manufacturer? No
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device?
Type of Device Usage Unkown

Patient Treatment Data
Date Received: 06/14/2018 Patient Sequence Number: 1
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