MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional report with the FDA on 2018-02-16 for REALSEAL manufactured by Sybronendo.
[100397543]
Specific patient information with regards to age, gender, weight was not provided. The patients required a re-treatment of the root canal. The retreatment involved cleaning out the canal and then medicated with calcium hydroxide. The product was not returned and no lot number was provided; therefore, no evaluation can be conducted.
Patient Sequence No: 1, Text Type: N, H10
[100397544]
A doctor alleged that after treatment of a root canal with realseal he had to perform a root canal retreatment on a patient.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2016150-2018-00004 |
| MDR Report Key | 7278976 |
| Report Source | HEALTH PROFESSIONAL |
| Date Received | 2018-02-16 |
| Date of Report | 2018-02-16 |
| Date of Event | 2018-01-17 |
| Date Mfgr Received | 2018-01-17 |
| Date Added to Maude | 2018-02-16 |
| 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 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 | 2018-02-16 |
| Operator | DENTIST |
| Device Availability | N |
| Device Eval'ed by Mfgr | N |
| 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 | 2018-02-16 |