MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional report with the FDA on 2016-08-25 for NUPRO WHITE VARNISH, RASPBERRY 130213 manufactured by Dentsply Professional.
[52980685]
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 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
[52980686]
While using a nupro raspberry flavored white varnish, a (b)(6) pediatric patient experienced gingival swelling and soreness after application. The treatment took place approximately 2 weeks ago and the symptoms have not remediated. The patient has had trouble eating the past few days.
Patient Sequence No: 1, Text Type: D, B5
[61212609]
The device was evaluated 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 | 2424472-2016-00058 |
| MDR Report Key | 5903549 |
| Report Source | HEALTH PROFESSIONAL |
| Date Received | 2016-08-25 |
| Date of Report | 2016-07-28 |
| Date Mfgr Received | 2016-11-04 |
| Date Added to Maude | 2016-08-25 |
| 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 | 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 WHITE VARNISH, RASPBERRY |
| Generic Name | VARNISH, CAVITY |
| Product Code | LBH |
| Date Received | 2016-08-25 |
| Catalog Number | 130213 |
| Lot Number | 1510271 |
| Operator | DENTAL HYGIENIST |
| Device Availability | Y |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| 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 | 2016-08-25 |