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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: CHRISTOPH MIETHKE GMBH & CO. KG PROGAV 2.0 SYS PAED.M.SA20 U.VORKAMMER HYDROCEPHALUS MANAGEMENT

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CHRISTOPH MIETHKE GMBH & CO. KG PROGAV 2.0 SYS PAED.M.SA20 U.VORKAMMER HYDROCEPHALUS MANAGEMENT Back to Search Results
Model Number FX441T
Device Problems Mechanical Problem (1384); Infusion or Flow Problem (2964)
Patient Problem Hydrocephalus (3272)
Event Date 10/07/2020
Event Type  Injury  
Manufacturer Narrative
The product for investigation has not yet reached us. When additional informations are provided, a follow up will be submitted.
 
Event Description
It was reported that there was a problem with a progav 2. 0 valve. Initial surgery placed progav on (b)(6) 2017. (b)(6) 2020, it was confirmed that the pressure could not be changed. (b)(6) 2020, the product was extracted due to suspected valve blockage. No further information available.
 
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Brand NamePROGAV 2.0 SYS PAED.M.SA20 U.VORKAMMER
Type of DeviceHYDROCEPHALUS MANAGEMENT
Manufacturer (Section D)
CHRISTOPH MIETHKE GMBH & CO. KG
ulanenweg 2
potsdam, 14469
GM
Manufacturer (Section G)
CHRISTOPH MIETHKE GMBH & CO. KG
ulanenweg 2
potsdam, 14469
GM 14469
Manufacturer Contact
jörg knebel
ulanenweg 2
potsda,, 14469
GM   14469
MDR Report Key11089827
MDR Text Key229839163
Report Number3004721439-2020-00268
Device Sequence Number1
Product Code JXG
Combination Product (y/n)N
Reporter Country CodeJA
PMA/PMN Number
K161853
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 02/19/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/29/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date09/22/2021
Device Model NumberFX441T
Device Catalogue NumberFX441T
Device Lot Number20032159
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer01/04/2021
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received01/26/2021
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured11/08/2016
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: 12/29/2020 Patient Sequence Number: 1
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