MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional report with the FDA on 2019-02-08 for PIEZOSURGERY 02890008 manufactured by Mectron S.p.a..
[135682070]
The manufacturer required to the (b)(6) to return the device to do the related investigation. The device was not returned.
Patient Sequence No: 1, Text Type: N, H10
[135682071]
The customer indicates: burns the mucosa of the lower left lip that immediately reaches the point of eating despite irrigation. The handpiece must be repaired. Consequences;: prolongation of surgery.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3003933619-2018-00002 |
| MDR Report Key | 8320979 |
| Report Source | HEALTH PROFESSIONAL |
| Date Received | 2019-02-08 |
| Date of Report | 2018-06-07 |
| Date of Event | 2018-04-23 |
| Date Added to Maude | 2019-02-08 |
| 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, GENOA 16042 |
| Manufacturer Country | IT |
| Manufacturer Postal | 16042 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | PIEZOSURGERY |
| Generic Name | PIEZOSURGERY 3 |
| Product Code | JDX |
| Date Received | 2019-02-08 |
| Model Number | 02890008 |
| Catalog Number | 02890008 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | N |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | MECTRON S.P.A. |
| Manufacturer Address | VIA LORETO 15/A / CARASCO, GENOA , ITALY 16042 IT 16042 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2019-02-08 |