MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional report with the FDA on 2018-12-26 for SYBRONENDO 973-0322REP manufactured by Sybronendo.
[131582593]
No patient information was provided in regards to ethnicity, and race. The product has been identified as a potential affected product in an ongoing class ii recall; therefore no further evaluation is necessary.
Patient Sequence No: 1, Text Type: N, H10
[131582594]
A complainant alleged the unit is overheating and assistant burned their finger. The assistant did not require a visit to a physician office. It was reported that the assistant has fully recovered.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2016150-2018-00064 |
| MDR Report Key | 8197500 |
| Report Source | HEALTH PROFESSIONAL |
| Date Received | 2018-12-26 |
| Date of Report | 2018-12-26 |
| Date of Event | 2018-11-27 |
| Date Mfgr Received | 2018-12-26 |
| Date Added to Maude | 2018-12-26 |
| 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 | ELEMENTS OBTURATION UNIT |
| Product Code | EKZ |
| Date Received | 2018-12-26 |
| Catalog Number | 973-0322REP |
| Lot Number | 91-25387 |
| 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 | 2018-12-26 |