MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional report with the FDA on 2016-06-15 for IPS E.MAX CAD LT 648189 manufactured by Ivoclar Vivadent Ag.
[47453934]
A patient symptom form was received back from customer in regards to a patient that seems to be having a reaction to a few crowns (on #s 7,9,10) and a veneer (# 8). Since their placement, the patient has been complaining of constant lip pain, lip swelling, lack of taste on roof of mouth and speech problems. Also, there appears to be a callous formation on her lip where the crowns and veneer are. Readjustment was attempted 21 different times. #7 and 8 were removed and sent back to colonial dental lab for adjustment and re-glazing. #9 was removed and replaced, and #8 was adjusted chairside. Patient was referred to a couple specialists (prosthodontist and allergist), but did not follow up with them.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 9612352-2016-00001 |
| MDR Report Key | 5726854 |
| Report Source | HEALTH PROFESSIONAL |
| Date Received | 2016-06-15 |
| Date of Report | 2016-04-25 |
| Date of Event | 2015-05-21 |
| Date Mfgr Received | 2016-04-25 |
| Date Added to Maude | 2016-06-15 |
| 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 | MS. DONNA HARTNETT |
| Manufacturer Street | 175 PINEVIEW DRIVE |
| Manufacturer City | AMHERST NY 14228 |
| Manufacturer Country | US |
| Manufacturer Postal | 14228 |
| Manufacturer Phone | 7166912260 |
| Manufacturer G1 | IVOCLAR VIVADENT AG |
| Manufacturer Street | BENDERERSTRASSE 2 |
| Manufacturer City | SCHAAN, 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 CAD LT |
| Generic Name | PORCELAIN/POWDER |
| Product Code | EIH |
| Date Received | 2016-06-15 |
| Catalog Number | 648189 |
| 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, 9494 LS 9494 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2016-06-15 |