MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05 report with the FDA on 2008-02-22 for CERCON CERAM KISS GLAZE 67163503 manufactured by Dentsply Prosthetics.
[19176373]
It was reported that a patient developed swelling of the lips and gums with an itching sensation after use of a prosthetic fashioned using cercon ceram kiss glaze. The patient sought treatment from an allergy specialist and was determined to be allergic to cobalt, chromium, and cobalt dichloride (none of which are components of the kiss glaze); the exact treatment administered, if any, is unknown as of this report.
Patient Sequence No: 1, Text Type: D, B5
[19327194]
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. The device was not returned for evaluation and the lot number was not provided for retained-product testing and/or dhr review. Further information pertaining to outcome of this event will be reported if it becomes available.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 9681199-2008-00006 |
| MDR Report Key | 1001071 |
| Report Source | 05 |
| Date Received | 2008-02-22 |
| Date of Report | 2008-01-25 |
| Date of Event | 2008-01-24 |
| Date Mfgr Received | 2008-01-25 |
| Date Added to Maude | 2008-02-26 |
| 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 | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 0 |
| Event Location | 0 |
| Manufacturer Contact | HELEN LEWIS |
| Manufacturer Street | SUSQUEHANNA COMMERCE CENTER W. 221 W. PHILA. ST. STE. 60 |
| Manufacturer City | YORK PA 17401 |
| Manufacturer Country | US |
| Manufacturer Postal | 17401 |
| Manufacturer Phone | 7178457511 |
| Manufacturer G1 | DEGUDENT GMBH |
| Manufacturer Street | RODENBACHER CHAUSSEE 4 |
| Manufacturer City | HANAU/WOLFGANG D-63457 |
| Manufacturer Country | GM |
| Manufacturer Postal Code | D-63457 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | CERCON CERAM KISS GLAZE |
| Product Code | EIH |
| Date Received | 2008-02-22 |
| Model Number | NA |
| Catalog Number | 67163503 |
| Lot Number | UNK |
| ID Number | NA |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Implant Flag | N |
| Date Removed | B |
| Device Sequence No | 1 |
| Device Event Key | 970175 |
| Manufacturer | DENTSPLY PROSTHETICS |
| Manufacturer Address | YORK PA US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2008-02-22 |