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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 SA2.0 20 & CONTROL RES. HYDROCEPHALUS MANAGEMENT

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CHRISTOPH MIETHKE GMBH & CO KG PROGAV 2.0 SYS SA2.0 20 & CONTROL RES. HYDROCEPHALUS MANAGEMENT Back to Search Results
Model Number FX602T
Device Problem No Pressure (2994)
Patient Problem Patient Problem/Medical Problem (2688)
Event Date 08/24/2020
Event Type  Injury  
Event Description
It was reported that there was a blockage of a progav 2. 0 shuntsytsem and the control reservoir. The membran was caved in and was blocked. Implantation: (b)(6) 2020. Removal: (b)(6) 2020.
 
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Brand NamePROGAV 2.0 SYS SA2.0 20 & CONTROL RES.
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 Key10514726
MDR Text Key206374619
Report Number3004721439-2020-00179
Device Sequence Number1
Product Code JXG
Combination Product (y/n)N
Reporter Country CodeGM
PMA/PMN Number
K190174
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
Report Date 09/03/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received09/10/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberFX602T
Device Catalogue NumberFX602T
Device Lot Number20047518
Was Device Available for Evaluation? No Answer Provided
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received08/26/2020
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured04/24/2020
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? Yes
Type of Device Usage Initial

Patient Treatment Data
Date Received: 09/10/2020 Patient Sequence Number: 1
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