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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: CODMAN & SHURTLEFF, INC. / MEDOS S.A. CODMAN EXTERNAL DRAINAGE SYSTEM III SHUNT, CENTRAL NERVOUS SYSTEM & COMPS

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CODMAN & SHURTLEFF, INC. / MEDOS S.A. CODMAN EXTERNAL DRAINAGE SYSTEM III SHUNT, CENTRAL NERVOUS SYSTEM & COMPS Back to Search Results
Catalog Number 82-1730
Device Problem Air Leak (1008)
Patient Problem No Information (3190)
Event Type  Injury  
Manufacturer Narrative
(b)(4). Upon completion of the investigation a follow up report will be filed.
 
Event Description
Device misfunction. Air is coming out from the drip chamber to the patient line. The external ventricular drain has been replaced. No patient consequence was reported. No consequences to the patient - another like device was used.
 
Manufacturer Narrative
To date, we have still not received the product for evaluation or the lot number of the product. While we are unable to confirm the lot number associated with this complaint, a review of sales to this facility has been performed, and all lots of this product number sold to the customer in 2016 were reviewed. No discrepancies related to the reported complaint were noted. If additional relevant information is received in the future, the file will be reopened and a follow-up report will be submitted. At present, we consider this complaint to be closed.
 
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Brand NameCODMAN EXTERNAL DRAINAGE SYSTEM III
Type of DeviceSHUNT, CENTRAL NERVOUS SYSTEM & COMPS
Manufacturer (Section D)
CODMAN & SHURTLEFF, INC. / MEDOS S.A.
rue girardet 29
ch-2400 le locle
SZ
Manufacturer Contact
james kenney
325 paramount drive
raynham, MA 02767
5088282726
MDR Report Key5834852
MDR Text Key50813749
Report Number1226348-2016-10531
Device Sequence Number1
Product Code JXG
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K954021
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Reporter Occupation Medical Equipment Company Technician/Representative
Type of Report Initial,Followup
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received07/29/2016
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Catalogue Number82-1730
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received08/22/2016
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? No
Type of Device Usage Initial

Patient Treatment Data
Date Received: 07/29/2016 Patient Sequence Number: 1
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