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 2020-03-04 for PROGAV 2.0 WITH SHUNTASSISTANT 25 FX414T manufactured by Christoph Miethke Gmbh & Co. Kg.
[188543508]
When additional information becomes available a follow up report will be submitted.
Patient Sequence No: 1, Text Type: N, H10
[188543509]
It was reported that there is an issue with valve is not adjustable and under drains. The reporter indicated that a post-operative valve is under draining and is not adjustable. The device was explanted. Additional event details and patient information have not provided, however, have been requested.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3004721439-2020-00056 |
| MDR Report Key | 9787143 |
| Report Source | COMPANY REPRESENTATIVE,FOREIG |
| Date Received | 2020-03-04 |
| Date of Report | 2020-03-18 |
| Date of Event | 2020-02-06 |
| Date Mfgr Received | 2020-03-16 |
| Device Manufacturer Date | 2019-06-11 |
| Date Added to Maude | 2020-03-04 |
| 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 | 2020-03-04 |
| Returned To Mfg | 2020-02-11 |
| Model Number | FX414T |
| Catalog Number | FX414T |
| Lot Number | 20040281 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Age | DA |
| 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 | 2020-03-04 |