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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 Date 06/12/2016
Event Type  malfunction  
Manufacturer Narrative
(b)(4). It was not possible to investigate the complaint as no sample was returned for evaluation. If the sample is returned in the future, this complaint will be re-opened and evaluated. Review of the history device records was not possible as the lot number is unknown. At the present time this complaint is closed.
 
Event Description
Air is coming out from the drip chamber to the line. The incident has been noted in the intensive care unit. The hospital has been using the edsiii for many years. Incident not reported to (b)(6) by the hospital.
 
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 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 Key5768835
MDR Text Key48735138
Report Number1226348-2016-10465
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 foreign
Reporter Occupation
Type of Report Initial,Followup
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received07/05/2016
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue Number82-1730
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received07/28/2016
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

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