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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: CHRISTOPH MIETHKE GMBH & CO. KG PROGAV 2.0 SYS PED.W/SA20 A.BURRHOLE RES HYDROCEPHALUS MANAGEMENT

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CHRISTOPH MIETHKE GMBH & CO. KG PROGAV 2.0 SYS PED.W/SA20 A.BURRHOLE RES HYDROCEPHALUS MANAGEMENT Back to Search Results
Model Number FX448T
Device Problems Obstruction of Flow (2423); Infusion or Flow Problem (2964)
Patient Problem Patient Problem/Medical Problem (2688)
Event Date 12/10/2019
Event Type  Injury  
Manufacturer Narrative
If additional information becomes available a follow up report will be submitted.
 
Event Description
It was reported that shunt blockage occurred. Patient information was not provided. Additional information has been requested.
 
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Brand NamePROGAV 2.0 SYS PED.W/SA20 A.BURRHOLE RES
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 Key9583732
MDR Text Key188558397
Report Number3004721439-2020-00011
Device Sequence Number1
Product Code JXG
Combination Product (y/n)N
Reporter Country CodeSP
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 01/13/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received01/13/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberFX448T
Device Catalogue NumberFX448T
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 Received12/16/2019
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
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: 01/13/2020 Patient Sequence Number: 1
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