MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 01,05 report with the FDA on 2015-06-18 for GUTTACORE OBTURATORS A1702P0042500 manufactured by Dentsply Tulsa Dental Specialties.
[5808438]
In this event a dentist reported that he can bring guttacore obturators to only 80% in the root canal and then the obturator breaks off. The event outcome is unk as of this mdr eval. Add'l info has been requested but is not yet available.
Patient Sequence No: 1, Text Type: D, B5
[13471385]
There has been a previous report received where this malfunction resulted in a serious injury. Therefore, it must be presumed that recurrence of this malfunction could possible 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 is available for eval, though results are not available as of this report. Eval results will be submitted as they become available.
Patient Sequence No: 1, Text Type: N, H10
[54915769]
This report was submitted in error. This type of malfunction would not be likely to result in a serious injury. The clinician would simply add to the filling material with another obturator.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2320721-2015-00006 |
| MDR Report Key | 4862596 |
| Report Source | 01,05 |
| Date Received | 2015-06-18 |
| Date of Report | 2015-05-20 |
| Date Mfgr Received | 2015-05-20 |
| Date Added to Maude | 2015-07-15 |
| 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 | HELEN LEWIS |
| Manufacturer Street | 221 W PHILADELPHIA ST SUSQUEHANNA COMMERCE CTR W., 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 OBTURATORS |
| Generic Name | GUTTA-PERCHA |
| Product Code | EKM |
| Date Received | 2015-06-18 |
| Returned To Mfg | 2015-06-08 |
| Catalog Number | A1702P0042500 |
| Lot Number | 0000072473 |
| Device Expiration Date | 2019-10-31 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Eval'ed by Mfgr | N |
| 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 | 2015-06-18 |