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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: CHRISTOPH MIETHKE GMBH & CO. KG SHUNTASSISTANT 2.0 25; HYDROCEPHALUS MANAGEMENT
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CHRISTOPH MIETHKE GMBH & CO. KG SHUNTASSISTANT 2.0 25; HYDROCEPHALUS MANAGEMENT Back to Search Results
Model Number FX103T
Device Problems Infusion or Flow Problem (2964); Pressure Problem (3012)
Patient Problem Patient Problem/Medical Problem (2688)
Event Date 10/10/2019
Event Type  Injury  
Manufacturer Narrative
When additional information becomes available a follow up report will be submitted.
 
Event Description
It was reported that the valve has a blockage.The reporter indicated that a post operative valve has a blockage.The device was explanted.At the time of this report, additional event details and patient information have not been received.
 
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Brand Name
SHUNTASSISTANT 2.0 25
Type of Device
HYDROCEPHALUS 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 Key9450428
MDR Text Key170239876
Report Number3004721439-2019-00299
Device Sequence Number1
Product Code JXG
Combination Product (y/n)N
Reporter Country CodeDA
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
Report Date 12/11/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/11/2019
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model NumberFX103T
Device Catalogue NumberFX103T
Device Lot Number20041922
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer11/20/2019
Is the Reporter a Health Professional? Yes
Date Manufacturer Received11/12/2019
Was Device Evaluated by Manufacturer? No
Date Device Manufactured05/14/2019
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
Patient Outcome(s) Required Intervention;
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