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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: CHRISTOPH MIETHKE GMBH & CO. KG PROSA VALVE HYDROCEPHALUS MANAGEMENT

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CHRISTOPH MIETHKE GMBH & CO. KG PROSA VALVE HYDROCEPHALUS MANAGEMENT Back to Search Results
Model Number FV410T
Device Problem Infusion or Flow Problem (2964)
Patient Problems Failure of Implant (1924); Patient Problem/Medical Problem (2688)
Event Date 09/27/2019
Event Type  Injury  
Manufacturer Narrative
Height: 130 cm. When additional information becomes available, a follow up report will be submitted.
 
Event Description
It was reported that the valve over drained. The reporter indicated that a 6 year post-operative valve is over draining and required explantation. Additional details of the event and patient information is not available.
 
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Brand NamePROSA VALVE
Type of DeviceHYDROCEPHALUS MANAGEMENT
Manufacturer (Section D)
CHRISTOPH MIETHKE GMBH & CO. KG
2 ulanenweg
potsdam d, 14469
GM 14469
Manufacturer (Section G)
CHRISTOPH MIETHKE GMBH & CO. KG
2 ulanenweg
potsdam d, 14469
GM 14469
Manufacturer Contact
joerg knebel
2 ulanenweg
potsdam d, 14469
GM   14469
MDR Report Key9219198
MDR Text Key163340546
Report Number3004721439-2019-00259
Device Sequence Number1
Product Code JXG
Combination Product (y/n)N
Reporter Country CodeGM
PMA/PMN Number
K161853
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Reporter Occupation Other Health Care Professional
Type of Report Initial,Followup
Report Date 11/12/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received10/22/2019
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date12/31/2017
Device Model NumberFV410T
Device Catalogue NumberFV410T
Device Lot Number4505171947
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer09/30/2019
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received10/17/2019
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured07/02/2013
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: 10/22/2019 Patient Sequence Number: 1
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