MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05 report with the FDA on 2004-04-23 for PROFILE GT ROTARY INSTRUMENT GTR0804025 manufactured by Dentsply Tulsa Dental.
[312349]
The doctor reported separating a file in the patient's tooth during a dental procedure. Patient follow-up will be required and reported, as information becomes available.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2320721-2004-00213 |
| MDR Report Key | 551791 |
| Report Source | 05 |
| Date Received | 2004-04-23 |
| Date of Report | 2004-03-25 |
| Date of Event | 2004-03-25 |
| Date Mfgr Received | 2004-03-25 |
| Date Added to Maude | 2004-10-28 |
| 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 | 0 |
| Manufacturer Contact | DR PATRICIA KIHN |
| Manufacturer Street | 221 W. PHILA. ST., STE 60 |
| Manufacturer City | YORK PA 17404 |
| Manufacturer Country | US |
| Manufacturer Postal | 17404 |
| Manufacturer Phone | 7178457511 |
| Manufacturer G1 | DENTSPLY TULSA |
| Manufacturer Street | 608 ROLLING HILLS DR. |
| Manufacturer City | JOHNSON CITY TN 37604 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 37604 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | PROFILE GT ROTARY INSTRUMENT |
| Generic Name | DENTAL FILE |
| Product Code | EMR |
| Date Received | 2004-04-23 |
| Returned To Mfg | 2004-04-01 |
| Model Number | NA |
| Catalog Number | GTR0804025 |
| Lot Number | UNK |
| ID Number | NA |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Eval'ed by Mfgr | Y |
| Implant Flag | N |
| Date Removed | A |
| Device Sequence No | 1 |
| Device Event Key | 541318 |
| Manufacturer | DENTSPLY TULSA DENTAL |
| Manufacturer Address | 608 ROLLING HILLS DR. JOHNSON CITY TN 37601 US |
| Baseline Brand Name | PROFILE GT ROTARY INSTRUMENT |
| Baseline Generic Name | DENTAL FILE |
| Baseline Model No | NA |
| Baseline Catalog No | GTR0804025 |
| Baseline ID | 061902-761 (LOT |
| Baseline Device Family | PROFILE GT |
| Baseline Shelf Life [Months] | NA |
| Baseline PMA Flag | N |
| Baseline 510K PMN | N |
| Baseline Preamendment | N |
| Baseline Transitional | N |
| 510k Exempt | Y |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2004-04-23 |