MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional report with the FDA on 2018-02-23 for SYBRONENDO 952-0004 manufactured by Sybronendo.
[101122305]
No injuries or medical intervention was reported. No patient information was provided. The date of event is estimated because it was not provided. No information was provided in regards to the serial number, therefore device manufacturing date could not be determined. The device has not been returned to the manufacturer. The product has been identified as an affected product in an ongoing class ii recall; therefore, no further evaluation is necessary.
Patient Sequence No: 1, Text Type: N, H10
[101122306]
An alleged complaint was reported that a patient experienced discomfort after root canal treatment.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2016150-2018-00006 |
| MDR Report Key | 7292553 |
| Report Source | HEALTH PROFESSIONAL |
| Date Received | 2018-02-23 |
| Date of Report | 2018-02-23 |
| Date of Event | 2018-01-01 |
| Date Mfgr Received | 2018-02-23 |
| Date Added to Maude | 2018-02-23 |
| 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 |
| Health Professional | 0 |
| Initial Report to FDA | 0 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | MR. PAULO CALLE |
| Manufacturer Street | 1717 W COLLINS |
| 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 | GENDORA CA 91740 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 91740 |
| Single Use | 3 |
| Remedial Action | RC |
| Previous Use Code | 3 |
| Removal Correction Number | Z-0413-2018 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | SYBRONENDO |
| Generic Name | BUCHANAN HEAT PLUGGER |
| Product Code | EKR |
| Date Received | 2018-02-23 |
| Catalog Number | 952-0004 |
| Operator | DENTIST |
| Device Availability | * |
| 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 | 2018-02-23 |