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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: CHRISTOPHER METHKE GMBH & CO. KG PROGAV 2.0 SYS W/SA25 A.SPRUNG RESERVOIR HYDROCEPHALUS MANAGEMENT

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CHRISTOPHER METHKE GMBH & CO. KG PROGAV 2.0 SYS W/SA25 A.SPRUNG RESERVOIR HYDROCEPHALUS MANAGEMENT Back to Search Results
Model Number FX428T
Device Problem Restricted Flow rate (1248)
Patient Problem Failure of Implant (1924)
Event Date 01/15/2019
Event Type  malfunction  
Manufacturer Narrative
(b)(4). When additional information is received a follow up report will be submitted.
 
Event Description
It was reported by the healthcare professional "4m 18d po underdrain of valve. " additional information has been requested however, not yet received. If additional information is received a follow up report will be submitted.
 
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Brand NamePROGAV 2.0 SYS W/SA25 A.SPRUNG RESERVOIR
Type of DeviceHYDROCEPHALUS MANAGEMENT
Manufacturer (Section D)
CHRISTOPHER METHKE 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
nicole broyles
1 a raumantie
helsinki, MO 00350
FI   00350
MDR Report Key8310174
MDR Text Key135158393
Report Number3004721439-2019-00024
Device Sequence Number1
Product Code JXG
Combination Product (y/n)N
Reporter Country CodeGM
PMA/PMN Number
K161853
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type foreign,health professional
Reporter Occupation Other Health Care Professional
Type of Report Initial,Followup
Report Date 03/11/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received02/06/2019
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberFX428T
Device Catalogue NumberFX428T
Device Lot Number20038541
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer01/18/2019
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Distributor Facility Aware Date02/01/2019
Device Age6 MO
Event Location No Information
Date Manufacturer Received02/01/2019
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured07/19/2018
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: 02/06/2019 Patient Sequence Number: 1
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