MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05 report with the FDA on 2011-09-14 for NUPRO PROPHY PASTE 8012225 manufactured by Dentsply Professional.
[2161014]
In this event it was reported that the use of nupro flavored prophy paste with fluoride may have resulted in a pt developing a lesion or sore in their mouth. The dentist advised the pt to combat the reaction with the use of salt water rinses and benadryl in the event that it was potentially an allergic response.
Patient Sequence No: 1, Text Type: D, B5
[9470820]
While it is unk if the prophy paste 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 dependant 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 is available for eval, though has not been returned as of this report. Eval results will be submitted as they become available.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2515379-2011-00015 |
| MDR Report Key | 2254997 |
| Report Source | 05 |
| Date Received | 2011-09-14 |
| Date of Report | 2011-08-15 |
| Date of Event | 2011-08-11 |
| Date Mfgr Received | 2011-08-15 |
| Date Added to Maude | 2011-09-21 |
| 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 | 0 |
| Event Location | 0 |
| Manufacturer Contact | HELEN LEWIS |
| Manufacturer Street | 221 W. PHILADELPHIA ST., STE60 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 | NUPRO PROPHY PASTE |
| Product Code | EJR |
| Date Received | 2011-09-14 |
| Catalog Number | 8012225 |
| Lot Number | 09111203 |
| Device Expiration Date | 2011-11-01 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Eval'ed by Mfgr | N |
| 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 | 2011-09-14 |