MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-09-18 for EVEREDGE 2.0 SCALER manufactured by Hu-freidy Mfg Co., Llc.
[120893987]
Pt was being treated when the toe of an instrument broke and became logged in the mesial of tooth #2.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5079893 |
| MDR Report Key | 7889430 |
| Date Received | 2018-09-18 |
| Date of Report | 2018-09-14 |
| Date of Event | 2018-09-06 |
| Date Added to Maude | 2018-09-19 |
| Event Key | 0 |
| Report Source Code | Voluntary report |
| Manufacturer Link | N |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Reporter Occupation | OTHER HEALTH CARE PROFESSIONAL |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | EVEREDGE 2.0 SCALER |
| Generic Name | SCALER, PERIODONTIC |
| Product Code | EMN |
| Date Received | 2018-09-18 |
| Model Number | EVEREDGE 2.0 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Eval'ed by Mfgr | I |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | HU-FREIDY MFG CO., LLC |
| Manufacturer Address | CHICAGO IL 60618 US 60618 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2018-09-18 |