MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a distributor report with the FDA on 2020-02-10 for THD REVOLUTION 700017 manufactured by Thd Spa.
| Report Number | 3006680097-2020-00001 |
| MDR Report Key | 9687192 |
| Report Source | DISTRIBUTOR |
| Date Received | 2020-02-10 |
| Date of Report | 2020-02-05 |
| Date of Event | 2019-12-16 |
| Date Mfgr Received | 2020-01-13 |
| Device Manufacturer Date | 2017-08-25 |
| Date Added to Maude | 2020-02-10 |
| 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. MAURIZIO PANTALEONI |
| Manufacturer Street | VIA INDUSTRA, 1 |
| Manufacturer City | CORREGGIO, RE 42015 |
| Manufacturer Country | IT |
| Manufacturer Postal | 42015 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | THD REVOLUTION |
| Generic Name | THD REVOLUTION |
| Product Code | JAF |
| Date Received | 2020-02-10 |
| Returned To Mfg | 2020-01-21 |
| Model Number | 700017 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | THD SPA |
| Manufacturer Address | VIA INDUSTRIA, 1 CORREGGIO, 42015 IT 42015 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2020-02-10 |