MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05 report with the FDA on 2010-06-25 for JET FRESH 13020301 manufactured by Dentsply Professional.
[1339989]
It was reported that within an hour of a procedure performed using jet fresh prophy powder, the pt's face became flushed and the pt became thirsty. Within two hours, the pt reported developing stomach cramps and chills; blood pressure and heart rate became raised. That evening the pt reported having diarrhea. Twenty four hours following the procedure, the pt reported that the symptoms had resolved, though heart rate was high for two additional days. No intervention was required to treat the symptoms.
Patient Sequence No: 1, Text Type: D, B5
[8598555]
Though the symptoms of an acute allergic reaction are typically dermatological in nature and the symptoms reported in this case are not consistent with previously reported allergic reaction events involving similar products, the possibility that an allergic reaction occurred cannot be excluded. While it is unk if the jet fresh prophy powder used in this case caused or contributed to the pt'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 cfr 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 | 2424472-2010-00096 |
| MDR Report Key | 1739627 |
| Report Source | 05 |
| Date Received | 2010-06-25 |
| Date of Report | 2010-05-27 |
| Date Mfgr Received | 2010-05-27 |
| Date Added to Maude | 2010-07-01 |
| 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., STE. 60 SUSQUEHANNA COMMERCE CTR 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 | JET FRESH |
| Product Code | KOJ |
| Date Received | 2010-06-25 |
| Catalog Number | 13020301 |
| 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. Other | 2010-06-25 |