MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05 report with the FDA on 2010-06-18 for PROPHY-JET POWDER 13000201 manufactured by Dentsply Professional.
[16371773]
It was reported that during a procedure performed using prophy-jet powder, the patient felt something enter their nose and began sneezing and producing mucous; the patient's eyes also became swollen. The patient took an antihistamine to alleviate the symptoms and reported that the swelling resolved within a few days.
Patient Sequence No: 1, Text Type: D, B5
[16664008]
While it is unknown if the prophy-jet powder 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 is reportable per 21 crf part 803. 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 | 2424472-2010-00092 |
| MDR Report Key | 1731344 |
| Report Source | 05 |
| Date Received | 2010-06-18 |
| Date of Report | 2010-05-21 |
| Date Mfgr Received | 2010-05-21 |
| Date Added to Maude | 2010-06-24 |
| 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. PHILA. ST., ST. 60 SUSQUEHANNA COMMERCE CENTER W. |
| Manufacturer City | YORK PA 17401 |
| Manufacturer Country | US |
| Manufacturer Postal | 17401 |
| Manufacturer Phone | 7178457511 |
| Manufacturer G1 | DENTSPLY PROFESSIONAL |
| Manufacturer Street | 1301 SMILE WAY |
| Manufacturer City | YORK PA 17404 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 17404 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | PROPHY-JET POWDER |
| Product Code | KOJ |
| Date Received | 2010-06-18 |
| Catalog Number | 13000201 |
| 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 | YORK PA US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2010-06-18 |