MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05 report with the FDA on 2015-04-02 for GUTTACORE OBTURATOR (PINK) GCP04026 manufactured by Dentsply Tulsa Dental Specialties.
[16457625]
In this event, it was reported that a dentist overfilled a patient's canal with gutta-core; no intervention was required. A review of the dentist's technique showed that he did not have a clear understanding of the obturation technique employed. Dentsply reviewed the protocols for usage with the dentist.
Patient Sequence No: 1, Text Type: D, B5
[16695992]
While no serious injury resulted in this event, there have been previous reports received where overfilling of a root canal resulted in a serious injury. Therefore, it must be presumed that recurrence of this malfunction could possibly cause or contribute to a serious injury or require medical or surgical intervention to preclude such. As such, this event is reportable per 21 cfr part 803. The device was not returned for evaluation and the lot number was not provided for retained-product testing and/or dhr review.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2320721-2015-00004 |
| MDR Report Key | 4669529 |
| Report Source | 05 |
| Date Received | 2015-04-02 |
| Date of Report | 2015-03-04 |
| Date of Event | 2015-03-03 |
| Date Mfgr Received | 2015-03-04 |
| Date Added to Maude | 2015-05-14 |
| 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 Contact | HELEN LEWIS |
| Manufacturer Street | 221 W. PHILADELPHIA ST. STE. 60 |
| Manufacturer City | YORK PA 17401 |
| Manufacturer Country | US |
| Manufacturer Postal | 17401 |
| Manufacturer Phone | 7178457511 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | GUTTACORE OBTURATOR (PINK) |
| Generic Name | GUTTA-PERCHA |
| Product Code | EKM |
| Date Received | 2015-04-02 |
| Catalog Number | GCP04026 |
| Lot Number | UNK |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | DENTSPLY TULSA DENTAL SPECIALTIES |
| Manufacturer Address | JOHNSON CITY TN US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2015-04-02 |