MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2019-02-05 for HENRY SCHEIN INC. 900-4368 manufactured by Prima Dental Group.
[135003460]
While delivering a crown on a (b)(6) male patient, the entire bur fell out of the handpiece into the patient's mouth. The patient swallowed the bur and was sent for an x-ray. The dr. Confirmed the patient was fine and no additional medical attention was required. The dr. Stated there were no changes in the patient's condition reported.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2411236-2019-00001 |
| MDR Report Key | 8304911 |
| Date Received | 2019-02-05 |
| Date of Report | 2019-02-05 |
| Date of Event | 2019-01-10 |
| Date Facility Aware | 2019-01-22 |
| Report Date | 2019-02-05 |
| Date Reported to FDA | 2019-02-05 |
| Date Reported to Mfgr | 2019-02-05 |
| Date Added to Maude | 2019-02-05 |
| 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 INC. |
| Generic Name | CARBIDE BUR |
| Product Code | EJL |
| Date Received | 2019-02-05 |
| Returned To Mfg | 2019-01-31 |
| Catalog Number | 900-4368 |
| Lot Number | 1165450 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | PRIMA DENTAL GROUP |
| Manufacturer Address | STEPHENSON DRIVE WATERWELLS BUSINESS PARK GLOUCESTER, GL2 2AG UK GL2 2AG |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2019-02-05 |