MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a user facility report with the FDA on 2019-11-06 for NEUROVENT-P 092946-001 manufactured by Raumedic Ag.
Report Number | 3006942548-2019-00007 |
MDR Report Key | 9283720 |
Report Source | USER FACILITY |
Date Received | 2019-11-06 |
Date of Report | 2019-10-14 |
Date Mfgr Received | 2019-10-14 |
Device Manufacturer Date | 2018-11-05 |
Date Added to Maude | 2019-11-06 |
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 | 2019-11-06 |
Returned To Mfg | 2019-10-21 |
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 | 2019-11-06 |