MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2017-07-28 for ELEMENTS 8:1 HANDPIECE 065-1655 manufactured by Kavo Dental Gmbh.
[81359779]
An alleged complaint was reported that a file broke in the patient's canal resulting in the doctor extracting the patient's tooth.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2024312-2017-00001 |
| MDR Report Key | 6752319 |
| Date Received | 2017-07-28 |
| Date of Report | 2017-06-28 |
| Date of Event | 2017-06-28 |
| Date Facility Aware | 2017-06-28 |
| Date Added to Maude | 2017-07-28 |
| Event Key | 0 |
| Report Source Code | Distributor 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 | DENTIST |
| 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 | ELEMENTS 8:1 HANDPIECE |
| Generic Name | HANDPIECE |
| Product Code | DZN |
| Date Received | 2017-07-28 |
| Catalog Number | 065-1655 |
| Operator | DENTIST |
| Device Availability | Y |
| Device Age | DA |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | KAVO DENTAL GMBH |
| Manufacturer Address | BISMARKING 39 BIBERACH, 88400 GM 88400 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2017-07-28 |