MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,foreig report with the FDA on 2019-11-29 for PROGAV 2.0 WITH SHUNTASSISTANT 25 FX414T manufactured by Christoph Miethke Gmbh & Co. Kg.
Report Number | 3004721439-2019-00280 |
MDR Report Key | 9392011 |
Report Source | COMPANY REPRESENTATIVE,FOREIG |
Date Received | 2019-11-29 |
Date of Report | 2019-11-29 |
Date of Event | 2019-06-27 |
Date Mfgr Received | 2019-08-28 |
Device Manufacturer Date | 2019-01-31 |
Date Added to Maude | 2019-11-29 |
Event Key | 0 |
Report Source Code | Manufacturer report |
Manufacturer Link | Y |
Number of Patients in Event | 0 |
Adverse Event Flag | 3 |
Product Problem Flag | 3 |
Reprocessed and Reused Flag | 3 |
Reporter Occupation | OTHER HEALTH CARE PROFESSIONAL |
Health Professional | 3 |
Initial Report to FDA | 3 |
Report to FDA | 3 |
Event Location | 3 |
Manufacturer Contact | JOERG KNEBEL |
Manufacturer Street | 2 ULANENWEG |
Manufacturer City | POTSDAM D, 14469 |
Manufacturer Country | GM |
Manufacturer Postal | 14469 |
Manufacturer G1 | CHRISTOPH MIETHKE GMBH & CO. KG |
Manufacturer Street | 2 ULANENWEG |
Manufacturer City | POTSDAM D, 14469 |
Manufacturer Country | GM |
Manufacturer Postal Code | 14469 |
Single Use | 3 |
Previous Use Code | 3 |
Event Type | 3 |
Type of Report | 3 |
Brand Name | PROGAV 2.0 WITH SHUNTASSISTANT 25 |
Generic Name | HYDROCEPHALUS MANAGEMENT |
Product Code | JXG |
Date Received | 2019-11-29 |
Returned To Mfg | 2019-10-07 |
Model Number | FX414T |
Catalog Number | FX414T |
Lot Number | 20040622 |
Operator | HEALTH PROFESSIONAL |
Device Availability | R |
Device Eval'ed by Mfgr | Y |
Device Sequence No | 1 |
Device Event Key | 0 |
Manufacturer | CHRISTOPH MIETHKE GMBH & CO. KG |
Manufacturer Address | 2 ULANENWEG POTSDAM D, 14469 GM 14469 |
Patient Number | Treatment | Outcome | Date |
---|---|---|---|
1 | 0 | 1. Required No Informationntervention | 2019-11-29 |