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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: CHRISTOPHER METHKE GMBH & CO. KG PROGAV VALVE HYDROCEPHALUS VALVES

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CHRISTOPHER METHKE GMBH & CO. KG PROGAV VALVE HYDROCEPHALUS VALVES Back to Search Results
Model Number FV410T
Device Problem Obstruction of Flow (2423)
Patient Problem Failure of Implant (1924)
Event Type  malfunction  
Manufacturer Narrative
(b)(4). Date of event: unknown. Implant date: unknown. Explant date: unknown. Expiration date: unknown. Batch number: unknown. Height cm: 108. When additional information is received a follow up report will be submitted.
 
Event Description
It was reported by the healthcare professional "adjustment problems. " additional patient outcome and medical intervention information has been requested. When the additional information is received a follow up report will be submitted.
 
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Brand NamePROGAV VALVE
Type of DeviceHYDROCEPHALUS VALVES
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
615 lambert pointe drive
hazelwood, MO 63042
3145515988
MDR Report Key8157907
MDR Text Key130168960
Report Number3004721439-2018-00304
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 foreign,health professional
Reporter Occupation Other Health Care Professional
Type of Report Initial,Followup
Report Date 01/07/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/12/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberFV410T
Device Catalogue NumberFV410T
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Distributor Facility Aware Date12/14/2018
Event Location No Information
Date Manufacturer Received12/14/2018
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured09/18/2013
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: 12/12/2018 Patient Sequence Number: 1
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