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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MEDOS INTERNATIONAL SARL CERTAS PLUS INLINE WITH SIPHONGUARD VALVE ONLY SHUNT, CENTRAL NERVOUS SYSTEM & COMPS

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MEDOS INTERNATIONAL SARL CERTAS PLUS INLINE WITH SIPHONGUARD VALVE ONLY SHUNT, CENTRAL NERVOUS SYSTEM & COMPS Back to Search Results
Catalog Number 82-8804
Device Problem Fluid Leak (1250)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 11/06/2018
Event Type  malfunction  
Manufacturer Narrative
Udi - (b)(4). The device has been returned and is awaiting evaluation. A follow-up report will be submitted upon completion.
 
Event Description
As reported, during implantation, a certas plus valve was observed leaking from the reservoir. It was replaced with a new valve, the procedure completed. The surgeon commented that the valve should not have been damaged during the procedure. No further information was provided by the hospital. The valve will be returned.
 
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Brand NameCERTAS PLUS INLINE WITH SIPHONGUARD VALVE ONLY
Type of DeviceSHUNT, CENTRAL NERVOUS SYSTEM & COMPS
Manufacturer (Section D)
MEDOS INTERNATIONAL SARL
rue girardet 29
le locle CH 24 00
SZ CH 2400
Manufacturer (Section G)
MEDOS INTERNATIONAL SARL
rue girardet 29
le locle CH 24 00
SZ CH 2400
Manufacturer Contact
karen anigbo
11 cabot boulevard
mansfield, MA 02048
7819715608
MDR Report Key8128814
MDR Text Key129332370
Report Number1226348-2018-10841
Device Sequence Number1
Product Code JXG
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K152152
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Reporter Occupation
Type of Report Initial,Followup
Report Date 12/09/2018
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received12/04/2018
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue Number82-8804
Device Lot Number196492
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer11/22/2018
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received01/21/2019
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured06/18/2018
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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