MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a user facility report with the FDA on 2020-01-08 for NEUROVENT-P 092946-001 manufactured by Raumedic Ag.
| Report Number | 3006942548-2020-00001 |
| MDR Report Key | 9563486 |
| Report Source | USER FACILITY |
| Date Received | 2020-01-08 |
| Date of Report | 2019-12-11 |
| Date Mfgr Received | 2019-12-11 |
| Device Manufacturer Date | 2018-11-12 |
| Date Added to Maude | 2020-01-08 |
| 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 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | MR. REINER THIEM |
| Manufacturer Street | HERMANN-STAUDINGER-STRASSE 2 |
| Manufacturer City | HELMBRECHTS, 95233 |
| Manufacturer Country | GM |
| Manufacturer Postal | 95233 |
| Manufacturer G1 | RAUMEDIC AG |
| Manufacturer Street | AM M |
| Manufacturer City | ZW 08297 |
| Manufacturer Country | GM |
| Manufacturer Postal Code | 08297 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | NEUROVENT-P |
| Generic Name | NEUROLOGICAL CATHETER |
| Product Code | GWM |
| Date Received | 2020-01-08 |
| Returned To Mfg | 2019-12-13 |
| Model Number | 092946-001 |
| Catalog Number | 092946-001 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | RAUMEDIC AG |
| Manufacturer Address | AM M?HLGRABEN 10 ZW?NITZ, 08297 GM 08297 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2020-01-08 |