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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: CHRISTOPH MIETHKE GMBH & CO. KG PROGAV 2.0 VALVE HYDROCEPHALUS MANAGEMENT

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CHRISTOPH MIETHKE GMBH & CO. KG PROGAV 2.0 VALVE HYDROCEPHALUS MANAGEMENT Back to Search Results
Model Number FX410T
Device Problems Infusion or Flow Problem (2964); Pressure Problem (3012)
Patient Problem Patient Problem/Medical Problem (2688)
Event Date 11/01/2019
Event Type  Injury  
Manufacturer Narrative
When additional information becomes available a follow up report will be submitted.
 
Event Description
It was reported that the pressure could not be changed. The reporter indicated that at first the pressure was set to 10cm but since the patient did not feel well, the doctor tried to change the pressure to 8cm. Even though the doctor tried to change the pressure, it did not work well and change. The doctor tried to do pumping of the reservoir and to use fv407t after clicking the valve itself in order to change the pressure but the pressure could not be changed. A revision surgery was done. Additional event details have not been provided. A request for additional information has been made, however, not yet received.
 
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Brand NamePROGAV 2.0 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 Key9385563
MDR Text Key185102071
Report Number3004721439-2019-00285
Device Sequence Number1
Product Code JXG
Combination Product (y/n)N
Reporter Country CodeJA
PMA/PMN Number
K141687
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 12/10/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received11/27/2019
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date06/30/2021
Device Model NumberFX410T
Device Catalogue NumberFX410T
Device Lot Number20031407
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer11/13/2019
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received12/04/2019
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured07/21/2016
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: 11/27/2019 Patient Sequence Number: 1
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