MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05 report with the FDA on 2014-11-19 for REALSEAL manufactured by Sybronendo.
[21877639]
A doctor alleged that multiple patients had experienced failed root canals.
Patient Sequence No: 1, Text Type: D, B5
[22147780]
Specific information with regards to the number of patient affected, patient information such as gender, age, and weight were not provided. It is reported that the doctor is retreating the patients. Multiple attempts were made to the doctor's office to obtain further information; however, the doctor has remained unresponsive. The product was not returned and no lot number was provided; therefore, no evaluations can be conducted.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2016150-2014-00490 |
| MDR Report Key | 4262633 |
| Report Source | 05 |
| Date Received | 2014-11-19 |
| Date of Report | 2014-10-20 |
| Date Mfgr Received | 2014-10-20 |
| Date Added to Maude | 2014-11-19 |
| 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 | 0 |
| Event Location | 0 |
| Manufacturer Contact | MRS. KERRI CASINO |
| Manufacturer Street | 1717 W. COLLINS AVE |
| Manufacturer City | ORANGE CA 92867 |
| Manufacturer Country | US |
| Manufacturer Postal | 92867 |
| Manufacturer Phone | 7145167634 |
| 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 | GUTTA-PERCHA |
| Product Code | EKM |
| Date Received | 2014-11-19 |
| 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 | 1. Other; 2. Required No Informationntervention | 2014-11-19 |