MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional report with the FDA on 2018-11-01 for REALSEAL manufactured by Sybronendo.
[125909586]
Specific patient information with regards to age, gender, ethnicity, race and weight was not provided. No lot number was provided therefore manufacture date cannot be determined. The product was not returned and no lot number or part number was provided; therefore, no evaluation can be conducted.
Patient Sequence No: 1, Text Type: N, H10
[125909587]
A complainant alleged that when performing a resilon re-treatment the following was noted, breakdown of the resilon material, gooey, soft, and periapical infection. The case was retreated with gentle wave. It was reported that there are no internal fractures and prognosis fair to good.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2016150-2018-00059 |
| MDR Report Key | 8031283 |
| Report Source | HEALTH PROFESSIONAL |
| Date Received | 2018-11-01 |
| Date of Report | 2018-11-01 |
| Date Mfgr Received | 2018-11-01 |
| Date Added to Maude | 2018-11-01 |
| 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 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | REALSEAL |
| Generic Name | RESIN, ROOT CANAL FILLING, |
| Product Code | KIF |
| Date Received | 2018-11-01 |
| 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 | 1. Other | 2018-11-01 |