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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: CHRISTOPH MIETHKE GMBH & CO KG PROGAV 2.0 WITH DISTAL CATHETER HYDROCEPHALUS MANAGEMENT

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CHRISTOPH MIETHKE GMBH & CO KG PROGAV 2.0 WITH DISTAL CATHETER HYDROCEPHALUS MANAGEMENT Back to Search Results
Model Number FX417T
Device Problem Infusion or Flow Problem (2964)
Patient Problems Head Injury (1879); Hemorrhage/Bleeding (1888); Hydrocephalus (3272)
Event Date 04/09/2021
Event Type  Injury  
Manufacturer Narrative
Additional information/ investigation result will be submitted in a supplemental report.
 
Event Description
It was reported that there was an issue with fv046t + fx417t shunt system. According to the complainant, the valve was believed to be operating with blockage. The patient underwent a revision procedure. The complainant device was returned to the manufacturer for evaluation. No patient complications were reported as a result of the revision procedure. Patient information: (b)(6) years. Explantation: (b)(6) 2021. The same event: medwatch#3004721439-2021-00133.
 
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Brand NamePROGAV 2.0 WITH DISTAL CATHETER
Type of DeviceHYDROCEPHALUS MANAGEMENT
Manufacturer (Section D)
CHRISTOPH MIETHKE GMBH & CO KG
ulanenweg 2
potsdam, 14469
GM 14469
Manufacturer (Section G)
CHRISTOPH MIETHKE GMBH & CO KG
ulanenweg 2
potsdam, 14469
GM 14469
Manufacturer Contact
joerg knebel
ulanenweg 2
potsdam, 14469
GM   14469
MDR Report Key11849821
MDR Text Key252321946
Report Number3004721439-2021-00134
Device Sequence Number1
Product Code JXG
Combination Product (y/n)N
Reporter Country CodeJA
PMA/PMN Number
K161853
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,user f
Reporter Occupation Other Health Care Professional
Type of Report Initial,Followup
Report Date 06/22/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received05/19/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberFX417T
Device Catalogue NumberFX417T
Device Lot Number20048666
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer05/17/2021
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received06/17/2021
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured07/03/2020
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: 05/19/2021 Patient Sequence Number: 1
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