MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2019-10-25 for TIDI 9307 manufactured by Asa Dental Spa.
| Report Number | 2182318-2019-00003 |
| MDR Report Key | 9242463 |
| Date Received | 2019-10-25 |
| Date of Report | 2019-05-24 |
| Date Facility Aware | 2019-04-25 |
| Report Date | 2019-05-24 |
| Date Reported to FDA | 2019-05-24 |
| Date Reported to Mfgr | 2019-05-16 |
| Date Added to Maude | 2019-10-25 |
| 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 |
| Reporter Occupation | DENTIST |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | CHRIS RAHN |
| Manufacturer Street | 570 ENTERPRISE DRIVE |
| Manufacturer City | NEENAH, WI 54956 |
| Manufacturer Country | US |
| Manufacturer Postal | 54956 |
| Manufacturer Phone | 9207514300 |
| Manufacturer G1 | ASA DENTAL SPA |
| Manufacturer Street | VIA VALENZANA DI SOPRA 60-BOZZANO |
| Manufacturer City | MASSAROSA, 55054 |
| Manufacturer Country | IT |
| Manufacturer Postal Code | 55054 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | TIDI |
| Generic Name | SALIVA EJECTORS |
| Product Code | DYN |
| Date Received | 2019-10-25 |
| Model Number | 9307 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | N |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | ASA DENTAL SPA |
| Manufacturer Address | ITALY VIA VALENZANA DI SOPRA 60-BOZZANO, |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2019-10-25 |