MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05 report with the FDA on 2009-08-26 for JET FRESH 130203 manufactured by Dentsply Professional.
[21647451]
It was reported that a patient complained of dizziness and a sensation that air entered under the gums after jet-fresh prophy powder was directed at an impacted wisdom tooth during a routine cleaning procedure. The patient was immediately taken to an urgent care physician who noted that there was no sign of air emphysema and prescribed a steroid. The treating dentist also prescribed an anti-inflammatory medication and an antibiotic as a precaution.
Patient Sequence No: 1, Text Type: D, B5
[21826356]
While there is no indication that the device involved malfunctioned in this case, because the patient was prescribed medication, this event meets the criteria for reportability.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2424472-2009-00117 |
| MDR Report Key | 1458889 |
| Report Source | 05 |
| Date Received | 2009-08-26 |
| Date of Report | 2009-07-27 |
| Date Mfgr Received | 2009-07-27 |
| Date Added to Maude | 2009-09-03 |
| 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 | SUSQUEHANNA COMMERCE CENTER W. 221 W. PHILA. ST., STE. 60 |
| 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 | JET FRESH |
| Product Code | KOJ |
| Date Received | 2009-08-26 |
| Model Number | NA |
| Catalog Number | 130203 |
| Lot Number | UNK |
| ID Number | NA |
| 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 | 2009-08-26 |