MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional report with the FDA on 2018-03-28 for SYBRONENDO 952-0004 manufactured by Sybronendo.
[103933546]
No patient information was provided in regards to age, sex, weight, ethnicity, and race. Date of event is approximated based on the information provided. No information was provided in regards to the serial number, therefore device manufacturing date could not be determined. No injuries or medical intervention was reported. 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
[103933547]
Over the past six months, the doctor recalled approximately 2-3 instances of patients indicating that they felt heat during endodontic procedures. It was reported that there were no patient injuries or medical intervention.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2016150-2018-00012 |
| MDR Report Key | 7379272 |
| Report Source | HEALTH PROFESSIONAL |
| Date Received | 2018-03-28 |
| Date of Report | 2018-03-27 |
| Date of Event | 2017-10-01 |
| Date Mfgr Received | 2018-03-27 |
| Date Added to Maude | 2018-03-28 |
| 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 | Z-0413-2018 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | SYBRONENDO |
| Generic Name | FINE BUCHANAN PLUGGER |
| Product Code | EKR |
| Date Received | 2018-03-28 |
| Catalog Number | 952-0004 |
| Operator | DENTIST |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| 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 | 2018-03-28 |