MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-03-14 for HENRY SCHEIN 9004357 manufactured by Prima Dental.
[102399199]
During a composite filling procedure on the distal end of tooth#2, the bur came out of a dental handpiece and the patient swallowed the finishing bur. The dentist did not use a dental dam during this procedure. The patient was instructed to go for an x-ray; however, patient refused to get an x-ray taken.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2411236-2018-00006 |
| MDR Report Key | 7339178 |
| Date Received | 2018-03-14 |
| Date of Report | 2018-02-20 |
| Date of Event | 2018-02-13 |
| Date Facility Aware | 2018-02-20 |
| Report Date | 2018-03-14 |
| Date Reported to FDA | 2018-03-14 |
| Date Reported to Mfgr | 2018-03-14 |
| Date Added to Maude | 2018-03-14 |
| 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 | 3 |
| Brand Name | HENRY SCHEIN |
| Generic Name | CARBIDE BUR T&F 12 BLADE |
| Product Code | EJL |
| Date Received | 2018-03-14 |
| Catalog Number | 9004357 |
| Operator | DENTIST |
| Device Availability | N |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | PRIMA DENTAL |
| Manufacturer Address | STEPHENSON DRIVE BUSINESS PARK GLOUCESTER, GL2 2AG UK GL2 2AG |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2018-03-14 |