MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2019-07-10 for 72-00167-0 AEH-4 manufactured by Northgate Technologies Inc..
| Report Number | 0001450997-2019-00004 |
| MDR Report Key | 8778707 |
| Date Received | 2019-07-10 |
| Date of Report | 2019-07-10 |
| Device Manufacturer Date | 2008-01-01 |
| Date Added to Maude | 2019-07-10 |
| 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 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Generic Name | AEH-4 LITHOTRIPSY SYSTEM |
| Product Code | FFK |
| Date Received | 2019-07-10 |
| Model Number | 72-00167-0 |
| Catalog Number | AEH-4 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| 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 | 1. Required No Informationntervention | 2019-07-10 |