MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional,user faci report with the FDA on 2020-02-21 for CERETOM NL3000 manufactured by Neurologica Corporation.
| Report Number | 3004938766-2020-00002 |
| MDR Report Key | 9742475 |
| Report Source | HEALTH PROFESSIONAL,USER FACI |
| Date Received | 2020-02-21 |
| Date of Report | 2020-02-21 |
| Date of Event | 2020-01-21 |
| Date Mfgr Received | 2020-01-21 |
| Device Manufacturer Date | 2015-11-30 |
| Date Added to Maude | 2020-02-21 |
| 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 | DR. NINAD GUJAR |
| Manufacturer Street | 14 ELECTRONICS AVENUE |
| Manufacturer City | DANVERS, MA |
| Manufacturer Country | US |
| Manufacturer Phone | 5648632 |
| Manufacturer G1 | NEUROLOGICA CORPORATION |
| Manufacturer Street | 14 ELECTRONICS AVENUE |
| Manufacturer City | DANVERS, MA |
| Manufacturer Country | US |
| Single Use | 3 |
| Remedial Action | RP |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | CERETOM |
| Generic Name | COMPUTED TOMOGRAPHY X-RAY SYSTEM |
| Product Code | JAK |
| Date Received | 2020-02-21 |
| Model Number | NL3000 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | NEUROLOGICA CORPORATION |
| Manufacturer Address | 14 ELECTRONICS AVENUE DANVERS, MA US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2020-02-21 |