MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2004-09-24 for PROFILE GT GTR0803025 manufactured by Dentsply Tulsa.
[96702687]
In this incident there was no report of injury to the patient. However, as a result of this malfunction, the potential for surgical intervention exists (though inadvisable per expert opinion dated (b)(6) 2002) to preclude injury or illness that would necessitate medical or surgical intervention to preclude permanent damage to a body structure or permanent impairment of a body function as evidenced by previous reported events with similar files. This event, therefore, is reportable per 21cfr part 803. If additional information becomes available regarding the patient and/or the outcome, it will be provided via a follow-up medwatch report.
Patient Sequence No: 1, Text Type: N, H10
[96702688]
Practitioner was instrumenting in apical third when she encountered a curve and possibly exerted a bit too much pressure; the instrument separated at that point. Approximately 3-4 mm of instrument was left. Doctor plans to schedule a follow-up visit for the patient.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2320721-2004-00428 |
| MDR Report Key | 5555451 |
| Date Received | 2004-09-24 |
| Date of Report | 2004-08-25 |
| Date of Event | 2004-08-25 |
| Date Mfgr Received | 2004-08-25 |
| Date Added to Maude | 2016-04-07 |
| 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 | DR PATRICIA KIHN |
| Manufacturer Street | SUSQUEHANNA COMMERCE CENTER W. 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 | 0 |
| Brand Name | PROFILE GT |
| Generic Name | DENTAL FILE |
| Product Code | EMR |
| Date Received | 2004-09-24 |
| Model Number | NA |
| Catalog Number | GTR0803025 |
| Lot Number | UNK |
| ID Number | NA |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | DENTSPLY TULSA |
| Manufacturer Address | JOHNSON CITY TN 37604 US 37604 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2004-09-24 |