MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2017-11-30 for BRASSELER USA CARBIDE BUR H7.33.008 000193U7 manufactured by Brasseler U.s.a. Dental, Llc.
[94318030]
No product was returned. Burs from inventory were checked. All burs checked were found to meet specifications. Unable to determine cause of bur walk out, but may be due to a worn handpiece collet. This is an isolated occurrence.
Patient Sequence No: 1, Text Type: N, H10
[94318031]
Doctor noted bur would not stay in handpiece and a patient had one go down their throat. Patient was not sent for x-rays initially because was breathing fine and no issues after incident. Bur was found in stool later the next day. Follow up visit to dental office on (b)(6) 2017 noted patient was doing fine.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1032227-2017-00006 |
| MDR Report Key | 7071875 |
| Date Received | 2017-11-30 |
| Date of Report | 2017-11-30 |
| Date of Event | 2017-10-31 |
| Date Mfgr Received | 2017-10-31 |
| Date Added to Maude | 2017-11-30 |
| 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 | GIOVANNY ESPINOSA |
| Manufacturer Street | ONE BRASSELER BLVD |
| Manufacturer City | SAVANNAH GA 31419 |
| Manufacturer Country | US |
| Manufacturer Postal | 31419 |
| Manufacturer G1 | BRASSELER U.S.A. DENTAL, LLC |
| Manufacturer Street | ONE BRASSELER BLVD |
| Manufacturer City | SAVANNAH GA 31419 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 31419 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | BRASSELER USA CARBIDE BUR |
| Generic Name | DENTAL CARBIDE BUR |
| Product Code | EJL |
| Date Received | 2017-11-30 |
| Model Number | H7.33.008 |
| Catalog Number | 000193U7 |
| Operator | DENTIST |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | BRASSELER U.S.A. DENTAL, LLC |
| Manufacturer Address | ONE BRASSELER BLVD SAVANNAH GA 31419 US 31419 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2017-11-30 |