MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 00 report with the FDA on 2011-02-04 for UNKNOWN ESTHET-X 630XXX manufactured by Dentsply Caulk.
[20213323]
In this event it was reported by a patient with known chemical sensitivities, that one day after having a restoration placed using esthet-x, he experienced an itchy/scratchy throat and red corneas; no medical intervention was necessary. The patient also stated that a non-dentsply product named core paste was also used in this event.
Patient Sequence No: 1, Text Type: D, B5
[20593644]
While it is unknown which esthet-x was used in this case or if it 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 patient refused to disclose the doctor's contact information. 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
| Report Number | 2515379-2011-00001 |
| MDR Report Key | 1985700 |
| Report Source | 00 |
| Date Received | 2011-02-04 |
| Date of Report | 2011-01-11 |
| Date Mfgr Received | 2011-01-11 |
| Date Added to Maude | 2011-02-15 |
| 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 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 0 |
| Event Location | 0 |
| Manufacturer Contact | HELEN LEWIS |
| Manufacturer Street | 221 W. PHILADELPHIA ST, STE 60 SUSQUEHANNA COMMERCE CTR W |
| Manufacturer City | YORK PA 17401 |
| Manufacturer Country | US |
| Manufacturer Postal | 17401 |
| Manufacturer Phone | 7178457511 |
| Manufacturer G1 | DENTSPLY CAULK |
| Manufacturer Street | 38 WEST CLARKE AVE. |
| Manufacturer City | MILFORD DE 19963 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 19963 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | UNKNOWN ESTHET-X |
| Generic Name | UNKNOWN |
| Product Code | EID |
| Date Received | 2011-02-04 |
| Catalog Number | 630XXX |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | DENTSPLY CAULK |
| Manufacturer Address | MILFORD DE US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2011-02-04 |