MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05 report with the FDA on 2013-08-23 for NUPRO PROPHY PASTE 801313-5 manufactured by Dentsply Professional.
[3642302]
In this event a doctor called asking if "balsam of (b)(4)" was an ingredient in nupro because one of his former employees has indicated the development of an allergy while working at his practice and he believes he may be sued. No symptoms were reported and the doctor refused to complete an allergic reaction checklist because they do not have any further info.
Patient Sequence No: 1, Text Type: D, B5
[11233454]
Dentsply does not add balsam of (b)(4) as an ingredient in nupro. However, it may be present in some of the flavors. The flavor supplier does not disclose the composition so it could not be determined if any of the flavors have balsam of (b)(4) as an ingredient. While it is unknown if the device used in this case caused or contributed to the user's alleged allergic response, 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 complaint is not regarding a specific instance of an allergic reaction due to use of the material. It is believed that an allergy developed over time with a dental staff associate who regularly applied nupro to pt during prophylaxis treatments. Therefore, a device evaluation is not possible due to the nature of this complaint.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2515379-2013-00038 |
| MDR Report Key | 3315702 |
| Report Source | 05 |
| Date Received | 2013-08-23 |
| Date of Report | 2013-07-25 |
| Date Mfgr Received | 2013-07-25 |
| Date Added to Maude | 2013-08-30 |
| 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 | 0 |
| Event Location | 0 |
| Manufacturer Contact | HELEN LEWIS |
| Manufacturer Street | 221 W. PHILADELPHIA ST., STE. 60 |
| Manufacturer City | YORK PA 17401 |
| Manufacturer Country | US |
| Manufacturer Postal | 17401 |
| Manufacturer Phone | 7178457511 |
| Manufacturer G1 | DENTSPLY CAULK |
| Manufacturer Street | 38 WEST CLARKE 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 PROPHY PASTE |
| Product Code | EJR |
| Date Received | 2013-08-23 |
| Catalog Number | 801313-5 |
| Lot Number | UNK |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| 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 | 2013-08-23 |