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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: CHRISTOPH MIETHKE GMBH & CO. KG PROGAV SYSTEM W/SA 15 A.SPRUNG RESERVOIR HYDROCEPHALUS VALVES

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CHRISTOPH MIETHKE GMBH & CO. KG PROGAV SYSTEM W/SA 15 A.SPRUNG RESERVOIR HYDROCEPHALUS VALVES Back to Search Results
Model Number FV426T
Device Problem Fluid/Blood Leak (1250)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 10/29/2018
Event Type  malfunction  
Manufacturer Narrative
(b)(4). When additional information is received a follow up report will be submitted.
 
Event Description
It was reported that during an abdominal cavity surgical procedure, it was discovered that the distal of the shunt tube was leaking fluids. Additional patient outcome and medical intervention information has been requested. When the additional information is received a follow up report will be submitted.
 
Manufacturer Narrative
What was the outcome of the patient? normal. Was there a delay in surgery? no. Customer changed a new one of this product. Was there any intervention outcome? no. Was this the initial surgery or revision surgery? initial surgery.
 
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Brand NamePROGAV SYSTEM W/SA 15 A.SPRUNG RESERVOIR
Type of DeviceHYDROCEPHALUS VALVES
Manufacturer (Section D)
CHRISTOPH MIETHKE GMBH & CO. KG
2 ulanenweg
potsdam d, 14469
GM 14469
MDR Report Key8144122
MDR Text Key129776659
Report Number3004721439-2018-00300
Device Sequence Number1
Product Code JXG
Combination Product (y/n)N
PMA/PMN Number
K103003
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type foreign,health professional
Type of Report Initial,Followup,Followup
Report Date 02/06/2019
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received12/07/2018
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date07/25/2022
Device Model NumberFV426T
Device Catalogue NumberFV426T
Device Lot Number20034708
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer11/13/2018
Was the Report Sent to FDA?
Distributor Facility Aware Date01/24/2019
Device Age1 YR
Event Location No Information
Date Manufacturer Received01/24/2019
Is This a Reprocessed and Reused Single-Use Device? No

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