MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional report with the FDA on 2016-02-17 for PURIT ULTRASONIC TANK PT300S manufactured by Young Dental Manufacturing Co 1, Llc..
[38367105]
A dentist cut his hand on the ultrasonic cleaner basket. He said the edge was very sharp.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1941138-2016-00002 |
| MDR Report Key | 5441867 |
| Report Source | HEALTH PROFESSIONAL |
| Date Received | 2016-02-17 |
| Date of Report | 2016-01-21 |
| Date of Event | 2013-03-04 |
| Date Mfgr Received | 2013-03-04 |
| Date Added to Maude | 2016-02-17 |
| 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 | SARAH MOORE |
| Manufacturer Street | 13705 SHORELINE CT. E. |
| Manufacturer City | EARTH CITY MO 63045 |
| Manufacturer Country | US |
| Manufacturer Postal | 63045 |
| Manufacturer Phone | 3143440010 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | PURIT ULTRASONIC TANK |
| Generic Name | ULTRASONIC TANK BASKET |
| Product Code | FLG |
| Date Received | 2016-02-17 |
| Model Number | PT300S |
| Catalog Number | PT300S |
| Operator | DENTIST |
| Device Availability | N |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | YOUNG DENTAL MANUFACTURING CO 1, LLC. |
| Manufacturer Address | 13705 SHORELINE CT. E. EARTH CITY MO 63045 US 63045 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2016-02-17 |