• 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 PROGAV 2.0 WITH SHUNTASSISTANT 20 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 PROGAV 2.0 WITH SHUNTASSISTANT 20 HYDROCEPHALUS MANAGEMENT Back to Search Results
Model Number FX413T
Device Problems Infusion or Flow Problem (2964); Pressure Problem (3012)
Patient Problem Patient Problem/Medical Problem (2688)
Event Date 11/22/2019
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 and is not adjustable. The reporter indicated that a post operative valve is blocked and is not adjustable. The device was explanted. Additional event details have not been provided.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand NamePROGAV 2.0 WITH SHUNTASSISTANT 20
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 Key9508573
MDR Text Key182200082
Report Number3004721439-2019-00308
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 01/10/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/21/2019
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberFX413T
Device Catalogue NumberFX413T
Device Lot Number20036836
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer11/27/2019
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received12/11/2019
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured02/27/2018
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: 12/21/2019 Patient Sequence Number: 1
-
-