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MAUDE
MDR
9392455
MAUDE MDR 9392455
MDR report key
9392455
Report number
3004721439-2019-00303
Event key
0
Event type
3
Date of event
2019-06-12
Date received
2019-11-30
Adverse event
3
Product problem
3
Patients in event
0
Reporter occupation
100
Health professional
3
Initial report to FDA
3
Event location
3
Related Records
#
Product code JXG
Manufacturer Contact
#
Contact
MR. JOERG KNEBEL
Address
2 ULANENWEG POTSDAM D, 14469 GM
Report source
M
Manufacturer link flag
Y
Devices
#
Seq, Brand, Generic table
Seq
Brand
Generic
Manufacturer
Product code
Model
Catalog
Lot
PMA
510(k)
Implant
Evaluated
Availability
1
PROGAV 2.0 SYS SA2.0 25 & CONTROL RES.
HYDROCEPHALUS MANAGEMENT
CHRISTOPH MIETHKE GMBH & CO. KG
JXG
FX603T
FX603T
20041699
Y
R
Patients
#
Sequence, Received, Treatment table
Sequence
Received
Treatment
Outcome
1
2019-11-30
0
Event Narratives
#
No narrative records found.
Related GUDID Devices By Product Code
#
Primary DI, Brand, Company table
Primary DI
Brand
Company
Product code
Published
03760409441121
Sophysa
SOPHYSA
JXG
2026-06-05
03760409441138
Sophysa
SOPHYSA
JXG
2026-06-05
03760409441145
Sophysa
SOPHYSA
JXG
2026-06-05
03760409441152
Sophysa
SOPHYSA
JXG
2026-06-05
03760409441169
Sophysa
SOPHYSA
JXG
2026-06-05
03760409441176
Sophysa
SOPHYSA
JXG
2026-06-05
03760409441183
Sophysa
SOPHYSA
JXG
2026-06-05
03760409441190
Sophysa
SOPHYSA
JXG
2026-06-05
03760409441206
Sophysa
SOPHYSA
JXG
2026-06-05
03760409441213
Sophysa
SOPHYSA
JXG
2026-06-05
03760409441220
Sophysa
SOPHYSA
JXG
2026-06-05
03760409441237
Sophysa
SOPHYSA
JXG
2026-06-05
03760409441244
Sophysa
SOPHYSA
JXG
2026-06-05
03760409441251
Sophysa
SOPHYSA
JXG
2026-06-05
03760409441268
Sophysa
SOPHYSA
JXG
2026-06-05
10381780540618
CODMAN® HOLTER®
INTEGRA LIFESCIENCES PRODUCTION CORPORATION
JXG
2026-04-15
10381780540625
CODMAN® HOLTER® SALMON
INTEGRA LIFESCIENCES PRODUCTION CORPORATION
JXG
2026-04-15
10381780535362
CODMAN® CERTAS®
Integra LifeSciences Switzerland Sàrl
JXG
2025-06-30
10381780535379
CODMAN® CERTAS®
Integra LifeSciences Switzerland Sàrl
JXG
2025-06-30
10381780535881
CODMAN® CERTAS®
Integra LifeSciences Switzerland Sàrl
JXG
2025-06-30
10381780535928
CODMAN® CERTAS®
Integra LifeSciences Switzerland Sàrl
JXG
2025-06-30
10381780535942
CODMAN® CERTAS®
Integra LifeSciences Switzerland Sàrl
JXG
2025-06-30
10381780535393
CODMAN® CERTAS® Plus
Integra LifeSciences Switzerland Sàrl
JXG
2024-11-20
10381780535430
CODMAN® CERTAS® Plus
Integra LifeSciences Switzerland Sàrl
JXG
2024-11-20
10381780535829
CODMAN® CERTAS® Plus
Integra LifeSciences Switzerland Sàrl
JXG
2024-11-20
10381780535867
CODMAN® CERTAS® Plus
Integra LifeSciences Switzerland Sàrl
JXG
2024-11-20
10381780537014
CODMAN® BACTISEAL®
INTEGRA LIFESCIENCES PRODUCTION CORPORATION
JXG
2024-11-20
10381780537021
CODMAN® BACTISEAL®
INTEGRA LIFESCIENCES PRODUCTION CORPORATION
JXG
2024-11-20
10381780537038
CODMAN® BACTISEAL®
INTEGRA LIFESCIENCES PRODUCTION CORPORATION
JXG
2024-11-20
10381780537045
CODMAN® BACTISEAL®
INTEGRA LIFESCIENCES PRODUCTION CORPORATION
JXG
2024-11-20
Related PMN/PMA Records By Product Code
#
Type, Submission, Product code table
Type
Submission
Product code
Device
Applicant
Decision date
510(k)
K251598
JXG
Intellidrop
Brainspace, Inc.
2025-12-10
510(k)
K250636
JXG
Sophy Mini Monopressure Valve (SM1)
Sophysa
2025-11-28
510(k)
K252514
JXG
EVAC-MRI
Phasor Health, LLC
2025-11-05
510(k)
K243531
JXG
Codman Libertís Shunt Catheter with Bactiseal and Endexo Technology
Integra Lifesciences Production Corporation
2025-08-08
510(k)
K243552
JXG
Codman Libertís™ 1.5 mm EVD Catheter with Bactiseal® and Endexo® Technology with Luer Connection (821761); Codman Libertís™ 1.9 mm EVD Catheter with Bactiseal® and Endexo® Technology with Luer Connection (821762)
Integra Lifesciences Production Corporation
2025-08-06