MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a foreign,health professional report with the FDA on 2018-11-28 for CERAM-X UNIVERSAL NANO-CERAMIC RESTORATIVE 607.01.570 manufactured by Dentsply Detrey Gmbh.
[128715098]
While it is unknown if the device used in this case caused or contributed to the patient's symptoms, it is possible as allergic reactions to dental materials are known and reported, with medical consequences being dependent upon the severity of the individual allergic response and subsequent exposure to the same material. Therefore, this event meets the criteria for reportability per 21 cfr part 803. The device was not returned for evaluation and the lot number was not provided for retained-product testing and/or dhr review.
Patient Sequence No: 1, Text Type: N, H10
[128715099]
It was reported that a patient experienced an allergic reaction after the use of ceramx universal. Within the first week, the patient had blisters on the palate. The blisters subsided, however the patient has also had a feeling of dry mouth and salivary loss since the use of ceramx, which is still in place.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 8010638-2018-00012 |
| MDR Report Key | 8112795 |
| Report Source | FOREIGN,HEALTH PROFESSIONAL |
| Date Received | 2018-11-28 |
| Date of Report | 2018-11-28 |
| Date Mfgr Received | 2018-10-29 |
| Date Added to Maude | 2018-11-28 |
| 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. KARL NITTINGER |
| Manufacturer Street | 221 W. PHILADELPHIA ST. SUITE 60W |
| Manufacturer City | YORK PA 17401 |
| Manufacturer Country | US |
| Manufacturer Postal | 17401 |
| Manufacturer Phone | 7178494424 |
| Manufacturer G1 | DENTSPLY DETREY GMBH |
| Manufacturer Street | DETREY STRASSE 1 |
| Manufacturer City | KONSTANZ, 78467 |
| Manufacturer Country | GM |
| Manufacturer Postal Code | 78467 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | CERAM-X UNIVERSAL NANO-CERAMIC RESTORATIVE |
| Generic Name | MATERIAL, TOOTH SHADE, RESIN |
| Product Code | EBF |
| Date Received | 2018-11-28 |
| Model Number | NA |
| Catalog Number | 607.01.570 |
| Lot Number | UNK |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | DENTSPLY DETREY GMBH |
| Manufacturer Address | DETREY STRASSE 1 KONSTANZ, 78467 GM 78467 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2018-11-28 |