MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2019-10-17 for PIZOSURGERY MT4-10+ 03600010 manufactured by Mectron S.p.a..
| Report Number | 3003933619-2019-00008 |
| MDR Report Key | 9200925 |
| Date Received | 2019-10-17 |
| Date of Report | 2019-10-15 |
| Date of Event | 2019-09-03 |
| Date Mfgr Received | 2019-10-16 |
| Device Manufacturer Date | 2017-07-30 |
| Date Added to Maude | 2019-10-17 |
| 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. GIOVANNA ROMEO |
| Manufacturer Street | VIA LORETO 15/A / |
| Manufacturer City | CARASCO, ITALY 16042 |
| Manufacturer Country | IT |
| Manufacturer Postal | 16042 |
| Manufacturer G1 | MECTRON S.P.A. |
| Manufacturer Street | VIA LORETO 15/A / |
| Manufacturer City | CARASCO, 16042 |
| Manufacturer Country | IT |
| Manufacturer Postal Code | 16042 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | PIZOSURGERY |
| Generic Name | MT4-10+ |
| Product Code | JDX |
| Date Received | 2019-10-17 |
| Model Number | MT4-10+ |
| Catalog Number | 03600010 |
| Lot Number | 17001731 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | MECTRON S.P.A. |
| Manufacturer Address | VIA LORETO 15/A / CARASCO, 16042 IT 16042 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2019-10-17 |