MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-12-05 for NUPRO? WHITE VARNISH, INTEGRATED BRUSH MINT .4G 130322 manufactured by Dentsply Llc.
[129434235]
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 is available for evaluation, though results are not available as of this report. Evaluation results will be submitted as they become available.
Patient Sequence No: 1, Text Type: N, H10
[129434236]
While using nupro white varnish, integrated brush mint, a patient experienced an allergic reaction. The symptoms include tingling, burning, and swelling of the gum tissue and lips after the use of the product. The patient took benadryl to combat the reaction. She is still experiencing sore gum tissue, but the swelling has subsided.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2424472-2018-00192 |
| MDR Report Key | 8135406 |
| Date Received | 2018-12-05 |
| Date of Report | 2019-01-09 |
| Date of Event | 2018-10-30 |
| Date Mfgr Received | 2018-12-28 |
| Date Added to Maude | 2018-12-05 |
| 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 | 3 |
| Event Location | 3 |
| Manufacturer Contact | MR. KARL NITTINGER |
| Manufacturer Street | 221 W. PHILADELPHIA ST. SUITE 60W |
| Manufacturer City | YORK PA 17401 |
| Manufacturer Country | US |
| Manufacturer Postal | 17401 |
| Manufacturer Phone | 7178494424 |
| 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 | 0 |
| Brand Name | NUPRO? WHITE VARNISH, INTEGRATED BRUSH MINT .4G |
| Generic Name | VARNISH, CAVITY |
| Product Code | LBH |
| Date Received | 2018-12-05 |
| Returned To Mfg | 2018-11-08 |
| Model Number | NA |
| Catalog Number | 130322 |
| Lot Number | 170322 |
| Device Expiration Date | 2019-03-28 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Age | DA |
| Device Eval'ed by Mfgr | N |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | DENTSPLY LLC |
| Manufacturer Address | 1301 SMILE WAY YORK PA 17404 US 17404 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2018-12-05 |