MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a other report with the FDA on 2017-09-20 for IPS E.MAX PRESS LT 605273 manufactured by Ivoclar Vivadent, Ag.
[86747257]
Patient did not return the device.
Patient Sequence No: 1, Text Type: N, H10
[86747258]
Patient contacted ivoclar vivadent on august 17, 2017 with a complaint about a possible allergic reaction from an ips e. Max restoration. The patient reported that following the placement of an ips e. Max restoration on (b)(6) 2016, she returned to the dentist and the dentist recommended root canal therapy. The patient believed her problems were caused by an allergic reaction to the crown. On (b)(6) 2017, the patient requested that the doctor remove the crown and replace it with another material. The doctor declined the request and referred her for endo. The endodontist confirmed that she needed a root canal, but the patient did not feel it was necessary and believed she was suffering an allergic reaction. The patient provided an allergy list to ivoclar vivadent on august 28, 2017. The list was cross checked with ips e. Max ingredients. Ivoclar vivadent, ag confirmed on august 29, 2017 that none of the allergies listed were contained in ips e. Max. During a follow-up conversation on september 14, 2017 the customer confirmed to ivoclar that she had the crown removed and a root canal was performed. The patient is currently in a temporary restoration, and stated that her symptoms had gone away. The patient states she had additional allergy testing done and the report shows she is allergic to ips e. Max. The additional allergy test report has not been submitted for ivoclar vivadent to review. It is believed by the original dentist who treated her that she required endodontic treatment and that her symptoms were not related to an allergic reaction.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 9612352-2017-00003 |
| MDR Report Key | 6878727 |
| Report Source | OTHER |
| Date Received | 2017-09-20 |
| Date of Report | 2017-09-18 |
| Date of Event | 2016-12-02 |
| Date Mfgr Received | 2017-08-17 |
| Date Added to Maude | 2017-09-20 |
| 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 | PATIENT |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | MS DONNA HARTNETT |
| Manufacturer Street | 175 PINEVIEW DR |
| Manufacturer City | AMHERST NY 14228 |
| Manufacturer Country | US |
| Manufacturer Postal | 14228 |
| Manufacturer Phone | 7166912660 |
| Manufacturer G1 | IVOCLAR VIVADENT, AG |
| Manufacturer Street | BENDERERSTRASSE 2 |
| Manufacturer City | SCHAAN, LI 9494 |
| Manufacturer Country | LS |
| Manufacturer Postal Code | 9494 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | IPS E.MAX PRESS LT |
| Generic Name | POWDER, PORCELAIN |
| Product Code | EIH |
| Date Received | 2017-09-20 |
| Catalog Number | 605273 |
| Operator | DENTIST |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | IVOCLAR VIVADENT, AG |
| Manufacturer Address | BENDERERSTRASSE 2 SCHAAN, LI 9494 LS 9494 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2017-09-20 |