MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05 report with the FDA on 2009-12-10 for PROPHY-JET POWDER 13000201 manufactured by Dentsply Professional.
[1391732]
It was reported that an office worker developed a rash on multiple occasions following the use of prophy-jet powder by another staff member in a different room. The affected individual consulted an allergist, though it is unk whether any intervention was required and results of any testing performed are not available as of this report.
Patient Sequence No: 1, Text Type: D, B5
[8343724]
While it is unk if the powder used in this case caused or contributed to the 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.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2424472-2009-00196 |
| MDR Report Key | 1561896 |
| Report Source | 05 |
| Date Received | 2009-12-10 |
| Date of Report | 2009-11-11 |
| Date Mfgr Received | 2009-11-11 |
| Date Added to Maude | 2009-12-23 |
| 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 |
| 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 | PROPHY-JET POWDER |
| Product Code | KOJ |
| Date Received | 2009-12-10 |
| Model Number | NA |
| Catalog Number | 13000201 |
| Lot Number | 090526 |
| 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. Other | 2009-12-10 |