MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a distributor report with the FDA on 2018-06-22 for SYBRONENDO 952-0004 manufactured by Sybronendo.
[112049468]
No patient information was provided in regards to weight, ethnicity, and race. Date of event was not provided. No information was provided in regards to the serial number, therefore device manufacturing date could not be determined. This will be twenty-one (21) of twenty-four (24) medical device reports that will be submitted. The product has been identified as an affected product in an ongoing class ii recall; therefore no further evaluation is necessary.
Patient Sequence No: 1, Text Type: N, H10
[112049469]
An alleged complaint was reported that multiple patients suffered a tougher post-operative recovery. They felt a very high sensitivity due to higher heat.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2016150-2018-00042 |
| MDR Report Key | 7630005 |
| Report Source | DISTRIBUTOR |
| Date Received | 2018-06-22 |
| Date of Report | 2018-06-21 |
| Date Mfgr Received | 2018-06-21 |
| Date Added to Maude | 2018-06-22 |
| 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 | FINE BUCHANAN PLUGGER |
| Product Code | EKR |
| Date Received | 2018-06-22 |
| Catalog Number | 952-0004 |
| 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 | 2018-06-22 |