MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05 report with the FDA on 2012-10-24 for JET-FRESH PROPHY POWDER 13020301 manufactured by Dentsply Professional.
[2924170]
In this event it was reported by a doctor that when he used mint jet-fresh powder on a pt, she started complaining about pain and swelling. The doctor stated that he sent the pt to emergency care within the company where she was given prednisone.
Patient Sequence No: 1, Text Type: D, B5
[10311250]
While 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, this event is more likely the result of the material inadvertently being directed into the soft tissue, not an allergic response. As such, the administration of prednisone is unlikely to have been required to preclude permanent damage to a body structure and is not likely attributed to resolution of the symptoms. However, since administration of prednisone is considered medical intervention, regardless of whether it was the appropriate treatment or not, this event meets the criteria for reportability per 21 cfr part 803. The device is available for eval, though has not been returned as of this report. Eval results will be submitted as they become available.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2424472-2012-00001 |
| MDR Report Key | 2818356 |
| Report Source | 05 |
| Date Received | 2012-10-24 |
| Date of Report | 2012-09-28 |
| Date of Event | 2012-09-24 |
| Date Mfgr Received | 2012-09-28 |
| Device Manufacturer Date | 2012-02-07 |
| Date Added to Maude | 2012-11-06 |
| 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 17404 |
| Manufacturer Country | US |
| Manufacturer Postal | 17404 |
| 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 | JET-FRESH PROPHY POWDER |
| Product Code | KOJ |
| Date Received | 2012-10-24 |
| Catalog Number | 13020301 |
| Lot Number | 1202071 |
| Device Expiration Date | 2014-12-01 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | DA |
| Device Eval'ed by Mfgr | N |
| 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 | 2012-10-24 |