MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,health report with the FDA on 2020-02-20 for SONENDO GENTLEWAVE SYSTEM FG-002-00001 manufactured by Sonendo.
| Report Number | 3010817521-2020-00001 |
| MDR Report Key | 9736218 |
| Report Source | COMPANY REPRESENTATIVE,HEALTH |
| Date Received | 2020-02-20 |
| Date of Report | 2020-02-20 |
| Date of Event | 2019-10-10 |
| Date Mfgr Received | 2019-12-10 |
| Date Added to Maude | 2020-02-20 |
| 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 | ANGELA CHEN |
| Manufacturer Street | 26061 MERIT CIRCLE, SUITE 102 |
| Manufacturer City | LAGUNA HILLS, CA |
| Manufacturer Country | US |
| Manufacturer Phone | 7663636801 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | SONENDO GENTLEWAVE SYSTEM |
| Generic Name | ULTRASONIC SCALER |
| Product Code | ELC |
| Date Received | 2020-02-20 |
| Model Number | FG-002-00001 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | SONENDO |
| Manufacturer Address | 26061 MERIT CIRCLE, SUITE 102 LAGUNA HILLS, CA US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2020-02-20 |