MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional report with the FDA on 2018-04-05 for SYBRONENDO 973-0504-TYPEB manufactured by Sybronendo.
[104526038]
No patient information was provided in regards to age, sex, weight, ethnicity, and race. No information was provided of date of event, therefore the date was approximated. No injuries or medical intervention was reported. The product was not returned, however trend review for the serial number was conducted and there were no previous incidents of this kind.
Patient Sequence No: 1, Text Type: N, H10
[104526039]
A complainant alleged that the elements free backfill was getting hot when it came in contact with the patients lip, it caused a blister. It was reported that the patients lip healed and no other injuries or medical intervention was required.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2016150-2018-00016 |
| MDR Report Key | 7401033 |
| Report Source | HEALTH PROFESSIONAL |
| Date Received | 2018-04-05 |
| Date of Report | 2018-03-29 |
| Date of Event | 2018-03-06 |
| Date Mfgr Received | 2018-03-29 |
| Device Manufacturer Date | 2014-08-03 |
| Date Added to Maude | 2018-04-05 |
| 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 | SYBRONENDO |
| Generic Name | ELEMENTS FREE OBTURATION BACKFILL |
| Product Code | EKR |
| Date Received | 2018-04-05 |
| Catalog Number | 973-0504-TYPEB |
| Operator | DENTIST |
| Device Availability | N |
| Device Age | DA |
| 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 | 2018-04-05 |