MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional report with the FDA on 2017-02-17 for NUPRO WHITE VARNISH, RASPBERRY 130213 manufactured by Dentsply Professional.
[67744410]
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. A root cause could not be identified; the retain and dhr investigations met specifications. Reactions in sensitive patients is an identified residual risk; while unfortunate, the risk is outweighed by the medical benefits of the intended use of the product.
Patient Sequence No: 1, Text Type: N, H10
[67744411]
While using nupro white varnish (raspberry flavor) a patient experienced an allergic reaction and a burning sensation. The clinician was unwilling to provide more information.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2424472-2017-00008 |
| MDR Report Key | 6341201 |
| Report Source | HEALTH PROFESSIONAL |
| Date Received | 2017-02-17 |
| Date of Report | 2017-02-17 |
| Date Mfgr Received | 2017-01-19 |
| Device Manufacturer Date | 2016-12-07 |
| Date Added to Maude | 2017-02-17 |
| 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 | 2017-02-17 |
| Model Number | NA |
| Catalog Number | 130213 |
| Lot Number | 1612071 |
| Device Expiration Date | 2018-12-28 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| 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 | 2017-02-17 |