MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05 report with the FDA on 2006-09-14 for LOW MAIN TURBINE FOR STAR 430 PB HANDPIECE 102-4535 manufactured by Dental Instruments.
[1079669]
The doctor was performing crown and bridge work on a patient, when the bur walked out of the chuck, and was swallowed by the patient. The patient required two colonoscopy procedures to surgically remove the swallowed bur.
Patient Sequence No: 1, Text Type: D, B5
[8190230]
The doctor advised us that he had noticed the bur continued to slip prior to this event, and continued to use it without notifying us of the potential problem.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2437811-2006-00001 |
| MDR Report Key | 1348644 |
| Report Source | 05 |
| Date Received | 2006-09-14 |
| Date of Report | 2006-08-15 |
| Date of Event | 2006-05-18 |
| Date Mfgr Received | 2006-08-15 |
| Date Added to Maude | 2009-03-27 |
| 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 | 0 |
| Event Location | 0 |
| Manufacturer Street | 137 COMMERCIAL ST., SUITE 302 |
| Manufacturer City | PLAINVIEW NY 11803 |
| Manufacturer Country | US |
| Manufacturer Postal | 11803 |
| Manufacturer Phone | 5167192101 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | LOW MAIN TURBINE FOR STAR 430 PB HANDPIECE |
| Generic Name | DENTAL |
| Product Code | EJB |
| Date Received | 2006-09-14 |
| Returned To Mfg | 2006-09-05 |
| Catalog Number | 102-4535 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | DENTAL INSTRUMENTS |
| Manufacturer Address | PLAINVIEW NY US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2006-09-14 |