MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05 report with the FDA on 2008-06-27 for JET FRESH 13020301 manufactured by Dentsply Professional.
[865452]
It was reported that several patients developed swelling of the cheek after treatment with jet-fresh powder. The patients were administered benadryl as a result and the swelling reportedly resolved within one to two days.
Patient Sequence No: 1, Text Type: D, B5
[8067213]
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 sulcus or soft tissue, not an allergic response. As such, the administration of benadryl 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 benadryl is considered medical intervention, regardless of whether it was the appropriate treatment or not, the device involved was returned, evaluated for color, appearance, odor, and particle size distribution and found to be in specification. Additional lot number: 071115.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2424472-2008-00058 |
| MDR Report Key | 1066588 |
| Report Source | 05 |
| Date Received | 2008-06-27 |
| Date of Report | 2008-05-29 |
| Date of Event | 2008-02-04 |
| Date Mfgr Received | 2008-05-29 |
| Date Added to Maude | 2008-07-03 |
| 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 | 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 | 2008-06-27 |
| Returned To Mfg | 2008-06-09 |
| Model Number | NA |
| Catalog Number | 13020301 |
| Lot Number | 070321 |
| ID Number | NA |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| Implant Flag | N |
| Date Removed | B |
| Device Sequence No | 1 |
| Device Event Key | 1034877 |
| Manufacturer | DENTSPLY PROFESSIONAL |
| Manufacturer Address | YORK PA US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2008-06-27 |