MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2015-11-29 for CAVITRON JET-FRESH PROPHY POWDER WITH ALUMINIMUM TRIHYDROXIDE - SODIUM FREE 13020301 manufactured by Dentsply Professional.
[32390705]
There has been a previous report received where this malfunction resulted in a serious injury. Therefore, it must be presumed that recurrence of this malfunction could possibly cause or contribute to a serious injury or require medical or surgical intervention to preclude such. As such, this event is reportable per 21cfr 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
[32390706]
It was reported that while a customer was using jet-fresh powder, the powder was sprayed inside the gingival tissue of a patient and swelling followed.
Patient Sequence No: 1, Text Type: D, B5
[37072351]
Prophy powder is used in conjunction with an air polishing prophylaxis system and air polishing insert tip to polish the tooth enamel. The clinician controls the direction of the spray and the product is not intended to be sprayed of tissue surface. The root cause has been identified as improper use.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2424472-2015-00107 |
| MDR Report Key | 5253731 |
| Date Received | 2015-11-29 |
| Date of Report | 2015-10-28 |
| Date Mfgr Received | 2015-12-29 |
| Date Added to Maude | 2015-11-29 |
| 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 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 | CAVITRON JET-FRESH PROPHY POWDER WITH ALUMINIMUM TRIHYDROXIDE - SODIUM FREE |
| Generic Name | AIRBRUSH |
| Product Code | KOJ |
| Date Received | 2015-11-29 |
| Model Number | NA |
| Catalog Number | 13020301 |
| Lot Number | 1502021 |
| Device Expiration Date | 2017-09-17 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | DA |
| 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 | 2015-11-29 |