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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: CHRISTOPH MIETHKE GMBH & CO. KG PROGAV SHUNTSYSTEM HYDROCEPHALUS MANAGEMENT

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CHRISTOPH MIETHKE GMBH & CO. KG PROGAV SHUNTSYSTEM HYDROCEPHALUS MANAGEMENT Back to Search Results
Model Number FV442T
Device Problem Complete Blockage (1094)
Patient Problem Patient Problem/Medical Problem (2688)
Event Date 04/16/2020
Event Type  Injury  
Manufacturer Narrative
Investigation: height: 186 cm. Visual inspection: n/a. Permeability test: n/a. Adjustment test: n/a. Braking force and brake function test: n/a. Results: the shuntsystem was sent to us with bloody residues and tissue remnants. Against this background, the progav shuntsystem was assessed at the highest risk level for us. We do not have the necessary resources to investigate such contaminated products. We cannot remove this buildup of this kind without risking personal health. Under these conditions, an examination is not possible. We can exclude a defect at the time of release. The valve met all specifications of the final inspection when released from christoph miethke (b)(4).
 
Event Description
It was reported that a valve is blocked. The reporter indicate that a post operative valve is blocked. The device was explanted. Additional event details have not been provided.
 
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Brand NamePROGAV SHUNTSYSTEM
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
jörg knebel
ulanenweg 2
potsdam, 14469
GM   14469
MDR Report Key10082514
MDR Text Key192153411
Report Number3004721439-2020-00089
Device Sequence Number1
Product Code JXG
Combination Product (y/n)N
Reporter Country CodeGM
PMA/PMN Number
K103003
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type user facility
Reporter Occupation Other Health Care Professional
Type of Report Initial
Report Date 05/22/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received05/22/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date07/25/2013
Device Model NumberFV442T
Device Catalogue NumberFV442T
Device Lot Number20008061
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer04/21/2020
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received04/21/2020
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured07/29/2008
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: 05/22/2020 Patient Sequence Number: 1
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