MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2016-06-22 for NUPRO EXTRA CARE PROPHY PASTE, SPEARMINT POLISH WITH FLUORIDE 801600 manufactured by Dentsply Professional.
[47997975]
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. This report is for the second patient. The device is available for evaluation, though has not been returned as of this report. Evaluation results will be submitted as they become available.
Patient Sequence No: 1, Text Type: N, H10
[47997976]
It was reported that two patient's experienced an allergic reaction following treatment with nupro extra care polish spearmint. In the second patient, they reported that their tongue felt "tingly and big". The patient declined benadryl. The patient's symptoms abated approximately 30 minutes after treatment was completed.
Patient Sequence No: 1, Text Type: D, B5
[55162347]
Multiple unsuccessful attempts were made to obtain the device for evaluation. Retain product was tested and found to be within specification. Also, a dhr review was conducted with no discrepancies noted.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2424472-2016-00047 |
| MDR Report Key | 5743266 |
| Date Received | 2016-06-22 |
| Date of Report | 2016-05-26 |
| Date of Event | 2016-05-23 |
| Date Mfgr Received | 2016-08-22 |
| Date Added to Maude | 2016-06-22 |
| 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 | 0 |
| Initial Report to FDA | 0 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | MRS. HELEN LEWIS |
| Manufacturer Street | 221 W. PHILADELPHIA ST. SUITE 60W |
| Manufacturer City | YORK PA 17401 |
| Manufacturer Country | US |
| Manufacturer Postal | 17401 |
| Manufacturer Phone | 7178494229 |
| Manufacturer G1 | DENTSPLY CAULK |
| Manufacturer Street | 38 W. 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 | NUPRO EXTRA CARE PROPHY PASTE, SPEARMINT POLISH WITH FLUORIDE |
| Generic Name | AGENT, POLISHING, ABRASIVE, ORAL CAVITY |
| Product Code | EJR |
| Date Received | 2016-06-22 |
| Model Number | NA |
| Catalog Number | 801600 |
| Lot Number | UNK |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | DENTSPLY PROFESSIONAL |
| Manufacturer Address | 1301 SMILE WAY YORK PA 17404 US 17404 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2016-06-22 |