MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a foreign,health professional report with the FDA on 2019-06-28 for HANSON MEDICAL MALAR IMPLANT M 4 - 3 manufactured by Hanson Medical Inc.
| Report Number | 2031444-2019-00001 |
| MDR Report Key | 8745468 |
| Report Source | FOREIGN,HEALTH PROFESSIONAL |
| Date Received | 2019-06-28 |
| Date of Report | 2019-06-28 |
| Date of Event | 2019-05-24 |
| Date Mfgr Received | 2019-06-04 |
| Device Manufacturer Date | 2018-01-04 |
| Date Added to Maude | 2019-06-28 |
| 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 | MS. APRIL BARNETT |
| Manufacturer Street | 825 RIVERSIDE AVE. SUITE 2 |
| Manufacturer City | PASO ROBLES CA 93446 |
| Manufacturer Country | US |
| Manufacturer Postal | 93446 |
| Manufacturer Phone | 8052386295 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | HANSON MEDICAL MALAR IMPLANT |
| Generic Name | MALAR IMPLANT |
| Product Code | LZK |
| Date Received | 2019-06-28 |
| Model Number | M 4 - 3 |
| Catalog Number | M 4 - 3 |
| Lot Number | 15943 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | HANSON MEDICAL INC |
| Manufacturer Address | 825 RIVERSIDE AVE. SUITE 2 PASO ROBLES CA 93446 US 93446 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Hospitalization | 2019-06-28 |