MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 01,08 report with the FDA on 2012-10-24 for ZIRCATE PROPHY PASTE 677001 manufactured by Dentsply Caulk.
[3079848]
In this event it was reported that a pt with known allergies to many things experienced a potentially adverse reaction to zircate prophy paste used during a dental prophylaxis. As stated in the report the pt experienced redness and a burning sensation of the tongue. No medical intervention was required.
Patient Sequence No: 1, Text Type: D, B5
[10282259]
While it is unk if the device used in this case caused or contributed to the pt'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 eval 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 | 2515379-2012-00016 |
| MDR Report Key | 2818349 |
| Report Source | 01,08 |
| Date Received | 2012-10-24 |
| Date of Report | 2012-09-26 |
| Date Mfgr Received | 2012-09-26 |
| Date Added to Maude | 2012-11-06 |
| 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 |
| 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 | ZIRCATE PROPHY PASTE |
| Product Code | EJR |
| Date Received | 2012-10-24 |
| Catalog Number | 677001 |
| 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 CAULK |
| Manufacturer Address | MILFORD DE US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2012-10-24 |