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 2020-01-10 for NEBULAE I 7-650-00 manufactured by Northgate Technologies Inc..
| Report Number | 0001450997-2020-00001 |
| MDR Report Key | 9578467 |
| Report Source | COMPANY REPRESENTATIVE,HEALTH |
| Date Received | 2020-01-10 |
| Date of Report | 2020-01-10 |
| Date of Event | 2019-12-12 |
| Date Mfgr Received | 2019-12-12 |
| Device Manufacturer Date | 2019-02-01 |
| Date Added to Maude | 2020-01-10 |
| 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. TODD GATTO |
| Manufacturer Street | 1591 SCOTTSDALE COURT |
| Manufacturer City | ELGIN IL 60123 |
| Manufacturer Country | US |
| Manufacturer Postal | 60123 |
| Manufacturer Phone | 2248562250 |
| Manufacturer G1 | NORTHGATE TECHNOLOGIES INC. |
| Manufacturer Street | 1591 SCOTTSDALE COURT |
| Manufacturer City | ELGIN IL 60123 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 60123 |
| Single Use | 3 |
| Remedial Action | IN |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | NEBULAE I |
| Generic Name | INSUFFLATOR |
| Product Code | HIF |
| Date Received | 2020-01-10 |
| Model Number | 7-650-00 |
| Catalog Number | 7-650-00 |
| Device Availability | Y |
| Device Eval'ed by Mfgr | N |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | NORTHGATE TECHNOLOGIES INC. |
| Manufacturer Address | 1591 SCOTTSDALE COURT ELGIN IL 60123 US 60123 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2020-01-10 |