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 2020-03-19 for SPRUNG RESERVOIR SET W/DISTAL CATHETER FV046T manufactured by Christoph Miethke Gmbh & Co. Kg.
[188550866]
If additional information becomes available a follow up report will be submitted.
Patient Sequence No: 1, Text Type: N, H10
[188550867]
It was reported that there is an issue with valve. The reporter indicated that a post-operative valve does not flow properly, so, the surgeon did the revision surgery and implanted other company valve. The ventrical catheter and reservoir from miethke have been used together with the other company valve. Thus, the surgeon would like to know whether there was blockage of the valve. 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 | 3004721439-2020-00067 |
| MDR Report Key | 9853765 |
| Report Source | COMPANY REPRESENTATIVE,FOREIG |
| Date Received | 2020-03-19 |
| Date of Report | 2020-03-19 |
| Date of Event | 2020-02-27 |
| Date Mfgr Received | 2020-02-29 |
| Date Added to Maude | 2020-03-19 |
| 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 | SPRUNG RESERVOIR SET W/DISTAL CATHETER |
| Generic Name | HYDROCEPHALUS MANAGEMENT |
| Product Code | JXG |
| Date Received | 2020-03-19 |
| Model Number | FV046T |
| Catalog Number | FV046T |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| 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 | 2020-03-19 |