MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-06-13 for SYBRONENDO 815-1546 manufactured by Sybronendo.
[111000707]
No patient information was provided in regards to age, sex, weight, ethnicity, and race. Patient also had a filling done at the time however no information was provided about the products used and if those un-named products had been considered an issue. The product is not available for return, no evaluation can be conducted.
Patient Sequence No: 1, Text Type: N, H10
[111000708]
An alleged incident was reported that one female patient had an allergic reaction with a full body rash seven days after endodontic treatment with gutta percha. Patient was on clindamycin rx prior to endodontic treatment. The patient went to a medical doctor and the diagnosis was that she was allergic to gutta percha and not the clindamycin. It was reported that patient would require an extraction due to an issue the doctor did not want to disclose. The same patient had 2 other endodontic procedures done previously without issue with the same products. Patient still has the rash and has been prescribed steroid creams.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2016150-2018-00020 |
| MDR Report Key | 7599577 |
| Date Received | 2018-06-13 |
| Date of Report | 2018-06-13 |
| Date of Event | 2018-05-08 |
| Date Mfgr Received | 2018-06-13 |
| Date Added to Maude | 2018-06-13 |
| 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 |
| Health Professional | 0 |
| Initial Report to FDA | 0 |
| 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 G1 | SYRBONENDO |
| 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 | 0 |
| Brand Name | SYBRONENDO |
| Generic Name | TF ADAPTIVE GUTTA PERCHA POINT ASST. ML1, ML2 & ML3 - 50PK |
| Product Code | EKM |
| Date Received | 2018-06-13 |
| Catalog Number | 815-1546 |
| 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 | 2018-06-13 |