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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: CHRISTOPH MIETHKE GMBH & CO KG PROGAV SYS PED.W/SA 15 A.PRECHAMBER HYDROCEPHALUS MANAGEMENT

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CHRISTOPH MIETHKE GMBH & CO KG PROGAV SYS PED.W/SA 15 A.PRECHAMBER HYDROCEPHALUS MANAGEMENT Back to Search Results
Model Number FX440T
Device Problem Infusion or Flow Problem (2964)
Patient Problem Patient Problem/Medical Problem (2688)
Event Date 05/06/2020
Event Type  Injury  
Manufacturer Narrative
Additional information is transmitted in a follow-up report after the investigation.
 
Event Description
It was reported that there was a problem with a katheter from progav shuntsystem. Product was implanted in 2019. In (b)(6) 2020, the patient continued to be comatose and was hospitalized for reexamination. On (b)(6), an intraoperative exploration was carried out. During the exploration, no fluid flowed out of the abdominal cavity. The diagnosis was that the shunt pipe was blocked. Additional information about the patient are not available.
 
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Brand NamePROGAV SYS PED.W/SA 15 A.PRECHAMBER
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 Key10239354
MDR Text Key197949257
Report Number3004721439-2020-00135
Device Sequence Number1
Product Code JXG
Combination Product (y/n)N
Reporter Country CodeCH
PMA/PMN Number
K103003
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 08/21/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received07/07/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberFX440T
Device Catalogue NumberFX440T
Device Lot Number20035838
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer08/10/2020
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received08/10/2020
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured11/29/2017
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: 07/07/2020 Patient Sequence Number: 1
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