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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: CHRISTOPH MIETHKE GMBH & CO KG PAEDIGAV SYSTEM W/PRECHAMB.ON VALVE 9/24 HYDROCEPHALUS MANAGEMENT

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CHRISTOPH MIETHKE GMBH & CO KG PAEDIGAV SYSTEM W/PRECHAMB.ON VALVE 9/24 HYDROCEPHALUS MANAGEMENT Back to Search Results
Model Number FV306T
Device Problems Material Fragmentation (1261); Material Integrity Problem (2978)
Patient Problem Patient Problem/Medical Problem (2688)
Event Date 05/08/2020
Event Type  Injury  
Manufacturer Narrative
Investigation still pending. More information in the follow up report.
 
Event Description
It was reported that there was a problem with a paedigav. The doctor carried out the procedure as usual, upon closing the doctor noticed the shunt tubing was leaking. Further information are not yet available.
 
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Brand NamePAEDIGAV SYSTEM W/PRECHAMB.ON VALVE 9/24
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 Key10393171
MDR Text Key202510820
Report Number3004721439-2020-00157
Device Sequence Number1
Product Code JXG
Combination Product (y/n)N
Reporter Country CodeSF
PMA/PMN Number
K011030
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,Followup
Report Date 09/10/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received08/11/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberFV306T
Device Catalogue NumberFV306T
Device Lot Number20043553
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received08/12/2020
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured08/29/2019
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: 08/11/2020 Patient Sequence Number: 1
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