MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2019-08-08 for RESURGE ULTRASONIC BATH 2.0 GALLON 0060200FG manufactured by Dentsply Llc.
| Report Number | 2424472-2019-00126 |
| MDR Report Key | 8874856 |
| Date Received | 2019-08-08 |
| Date of Report | 2019-09-30 |
| Date Mfgr Received | 2019-09-12 |
| Date Added to Maude | 2019-08-08 |
| 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 |
| Reporter Occupation | DENTIST |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | MR. KARL NITTINGER |
| Manufacturer Street | 221 W. PHILADELPHIA ST. SUITE 60W |
| Manufacturer City | YORK PA 17401 |
| Manufacturer Country | US |
| Manufacturer Postal | 17401 |
| Manufacturer Phone | 7178494424 |
| Manufacturer G1 | SHENZHEN CODYSON ELECTRICAL CO, LTD |
| Manufacturer Street | 2-F MINLIDA, NANSHAN DISTRICT |
| Manufacturer City | SHENZHEN HEILONGJIANG, 518055 |
| Manufacturer Country | CH |
| Manufacturer Postal Code | 518055 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | RESURGE ULTRASONIC BATH 2.0 GALLON |
| Generic Name | CLEANER, ULTRASONIC, MEDICAL INSTRUMENT |
| Product Code | FLG |
| Date Received | 2019-08-08 |
| Returned To Mfg | 2019-07-19 |
| Model Number | NA |
| Catalog Number | 0060200FG |
| Lot Number | NA |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | DENTSPLY LLC |
| Manufacturer Address | 1301 SMILE WAY YORK PA 17404 US 17404 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2019-08-08 |