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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: CHRISTOPH MIETHKE GMBH & CO. KG PROSA VALVE HYDROCEPHALUS MANAGEMENT

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CHRISTOPH MIETHKE GMBH & CO. KG PROSA VALVE HYDROCEPHALUS MANAGEMENT Back to Search Results
Model Number FV701T
Device Problem Infusion or Flow Problem (2964)
Patient Problem Patient Problem/Medical Problem (2688)
Event Date 01/16/2020
Event Type  Injury  
Manufacturer Narrative
Height: 175cm. No tests have been performed. The valve was sent to us dry (i. E. Not submersed in liquid as recommended). An investigation of valves sent in dry is not meaningful, as the product characteristics can be influenced by dry residues of cerebrospinal fluid or blood and therefore cannot be evaluated by us. We ask for your understanding that we do not perform tests on products sent in this way. In our view, there is no further need for regulatory action. 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 not adjustable. The reporter indicated that a 2 month 1 day post-operative valve is not adjustable and required explantation. Additional event details were not provided.
 
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Brand NamePROSA VALVE
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 Key9668049
MDR Text Key186848521
Report Number3004721439-2020-00035
Device Sequence Number1
Product Code JXG
Combination Product (y/n)N
Reporter Country CodeGM
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 02/04/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received02/04/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberFV701T
Device Catalogue NumberFV701T
Device Lot Number20044238
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer01/20/2020
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received01/20/2020
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured10/17/2019
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: 02/04/2020 Patient Sequence Number: 1
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