MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 00,01 report with the FDA on 2013-03-21 for DELTON LIGHT CURE PIT AND FISSURE SEALANT 2796 manufactured by Dentsply Professional.
[3325115]
In this event it was reported that a patient experienced an allergic reaction to the use of delton, a product used as a sealant. The symptoms reported were swelling of the gingiva which lasted for two weeks. No medical intervention was necessary.
Patient Sequence No: 1, Text Type: D, B5
[10610173]
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. However, the lot number was provided and retained-product testing and/or dhr review are planned. The results will be submitted as they become available.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2515379-2013-00006 |
| MDR Report Key | 3030606 |
| Report Source | 00,01 |
| Date Received | 2013-03-21 |
| Date of Report | 2013-02-27 |
| Date of Event | 2013-02-16 |
| Date Mfgr Received | 2013-02-27 |
| Date Added to Maude | 2013-04-03 |
| 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 CTR. W. 221 W. PHILADELPHIA ST., STE 60 |
| Manufacturer City | YORK PA 17401 |
| Manufacturer Country | US |
| Manufacturer Postal | 17401 |
| Manufacturer Phone | 7178457511 |
| Manufacturer G1 | DENTSPLY CAULK |
| Manufacturer Street | 38 WEST CLARK 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 | DELTON LIGHT CURE PIT AND FISSURE SEALANT |
| Product Code | EBC |
| Date Received | 2013-03-21 |
| Catalog Number | 2796 |
| Lot Number | 120906 |
| 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 PROFESSIONAL |
| Manufacturer Address | YORK PA US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2013-03-21 |