MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional report with the FDA on 2018-02-05 for SYBRONENDO 952-0004 manufactured by Sybronendo.
[99783168]
No product lot number was provided therefore device manufacturing date could not be identified. It was identified that the patient was not injured however, just felt the heat sensation. Patient came in to do a follow up and was noted that there was no harm done. No additional follow ups are required. The product has been identified as part of an ongoing class ii recall; therefore, no further evaluation is necessary.
Patient Sequence No: 1, Text Type: N, H10
[99783169]
The doctor was using the elements obturation unit and the. 06 buchanan pluger when the patient complained she felt pain and heat on the actual structure of the tooth.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2016150-2018-00002 |
| MDR Report Key | 7242971 |
| Report Source | HEALTH PROFESSIONAL |
| Date Received | 2018-02-05 |
| Date of Report | 2018-01-08 |
| Date of Event | 2018-01-08 |
| Date Mfgr Received | 2018-01-08 |
| Date Added to Maude | 2018-02-05 |
| 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 | MR. PAULO CALLE |
| Manufacturer Street | 1717 W COLLINS AVENUE |
| Manufacturer City | ORANGE CA 92867 |
| Manufacturer Country | US |
| Manufacturer Postal | 92867 |
| Manufacturer Phone | 7145167752 |
| Manufacturer G1 | SYBRONENDO |
| Manufacturer Street | 1332 SOUTH LONE HILL AVENUE |
| Manufacturer City | GLENDORA CA 91740 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 91740 |
| Single Use | 3 |
| Remedial Action | RC |
| Previous Use Code | 3 |
| Removal Correction Number | 2016150-12/19/2017-001-R |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | SYBRONENDO |
| Generic Name | FINE BUCHANAN PLUGGER |
| Product Code | EKR |
| Date Received | 2018-02-05 |
| Catalog Number | 952-0004 |
| Operator | DENTIST |
| Device Availability | N |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | SYBRONENDO |
| Manufacturer Address | 1332 SOUTH LONE HILL AVENUE GLENDORA CA 91740 US 91740 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2018-02-05 |