MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,health report with the FDA on 2019-11-29 for CRANIAL NAVIGATION SOFTWARE (VERSION 3.1) 22216-02 19900 manufactured by Brainlab Ag.
Report Number | 8043933-2019-00061 |
MDR Report Key | 9391935 |
Report Source | COMPANY REPRESENTATIVE,HEALTH |
Date Received | 2019-11-29 |
Date of Report | 2019-09-18 |
Date of Event | 2019-09-16 |
Date Mfgr Received | 2019-09-18 |
Device Manufacturer Date | 2017-03-01 |
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 |
Health Professional | 3 |
Initial Report to FDA | 3 |
Report to FDA | 3 |
Event Location | 3 |
Manufacturer Contact | MR. MARKUS HOFMANN |
Manufacturer Street | OLOF-PALME-STRASSE 9 |
Manufacturer City | MUENCHEN, 81829 |
Manufacturer Country | GM |
Manufacturer Postal | 81829 |
Manufacturer G1 | BRAINLAB AG |
Manufacturer Street | OLOF-PALME-STRASSE 9 |
Manufacturer City | MUENCHEN, 81829 |
Manufacturer Country | GM |
Manufacturer Postal Code | 81829 |
Single Use | 3 |
Previous Use Code | 3 |
Event Type | 3 |
Type of Report | 3 |
Brand Name | CRANIAL NAVIGATION SOFTWARE (VERSION 3.1) |
Generic Name | IMAGE GUIDED SURGERY SYSTEM/INSTRUMENT, STEREOTAXIC |
Product Code | HAW |
Date Received | 2019-11-29 |
Model Number | 22216-02 |
Catalog Number | 19900 |
Lot Number | SW V. 3.1.1 |
Operator | HEALTH PROFESSIONAL |
Device Availability | Y |
Device Eval'ed by Mfgr | Y |
Device Sequence No | 1 |
Device Event Key | 0 |
Manufacturer | BRAINLAB AG |
Manufacturer Address | OLOF-PALME-STRASSE 9 MUENCHEN, 81829 GM 81829 |
Patient Number | Treatment | Outcome | Date |
---|---|---|---|
1 | 0 | 1. Hospitalization; 2. Other | 2019-11-29 |