• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

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

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

CHRISTOPH MIETHKE GMBH & CO. KG PROSA VALVE HYDROCEPHALUS MANAGEMENT Back to Search Results
Model Number FV701T
Device Problems Infusion or Flow Problem (2964); Pressure Problem (3012)
Patient Problem Patient Problem/Medical Problem (2688)
Event Date 12/03/2019
Event Type  Injury  
Manufacturer Narrative
When additional information becomes available a follow up report will be submitted.
 
Event Description
It was reported that a valve is blocked. The reporter indicated that due to the ventricular enlargement, the surgeon tried pumping but it did not flow well. Thus, emergency replacement surgery was implemented. The pressure of the valve was not changed then. Since (b)(4) has been just replaced in november, the blockage might have been caused by (b)(4). Patient information was not provided. Additional information has been requested.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

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 Key9560634
MDR Text Key188559992
Report Number3004721439-2020-00002
Device Sequence Number1
Product Code JXG
Combination Product (y/n)N
Reporter Country CodeJA
PMA/PMN Number
K120559
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 01/27/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received01/07/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberFV701T
Device Catalogue NumberFV701T
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received01/10/2020
Was Device Evaluated by Manufacturer? Yes
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: 01/07/2020 Patient Sequence Number: 1
-
-