MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,health professional report with the FDA on 2015-04-14 for NUPRO PROPHY PASTE 801211 manufactured by Dentsply Professional.
[5644314]
In this event it was reported that while using nupro prophy paste (orange), a patient began to experience an allergic reaction. The patient has a known allergy to red dyes and her lips began to swell upon initial use. The patient did not require medical intervention.
Patient Sequence No: 1, Text Type: D, B5
[13160433]
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
[63964169]
Multiple unsuccessful attempts were made to obtain the device for evaluation. The device was not returned for evaluation and the lot number was not provided for retained-product testing and/or dhr review.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2424472-2015-00013 |
| MDR Report Key | 4702898 |
| Report Source | 05,HEALTH PROFESSIONAL |
| Date Received | 2015-04-14 |
| Date of Report | 2015-03-20 |
| Date Mfgr Received | 2015-03-20 |
| Date Added to Maude | 2015-04-20 |
| 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 | HELEN LEWIS |
| Manufacturer Street | 221 W. PHILADELPHIA ST., STE 60 SUSQUEHANNA COMMERCE CTR W. |
| Manufacturer City | YORK PA 17401 |
| Manufacturer Country | US |
| Manufacturer Postal | 17401 |
| Manufacturer Phone | 7178457511 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | NUPRO PROPHY PASTE |
| Generic Name | ORAL CAVITY ABRASIVE POLISHING AGENT |
| Product Code | EJR |
| Date Received | 2015-04-14 |
| Catalog Number | 801211 |
| Lot Number | UNK |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Eval'ed by Mfgr | R |
| 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 | 2015-04-14 |