MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 1994-02-07 for PROPHY JET CLEANING POWDER-2 manufactured by Dentsply.
[9432]
Pt received a chemical burn to the eye. Her eye also blistered from chemical, and the chemical was not sprayed into pt's eye. What got into her eye was what was floating in the air.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW4000203 |
| MDR Report Key | 11518 |
| Date Received | 1994-02-07 |
| Date of Report | 1993-04-16 |
| Date of Event | 1993-03-25 |
| Date Added to Maude | 1994-02-17 |
| Event Key | 0 |
| Report Source Code | Voluntary report |
| Manufacturer Link | N |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 0 |
| Health Professional | 3 |
| Initial Report to FDA | 0 |
| Report to FDA | 0 |
| Event Location | 3 |
| Single Use | 0 |
| Previous Use Code | 0 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | PROPHY JET CLEANING POWDER-2 |
| Product Code | KJJ |
| Date Received | 1994-02-07 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | * |
| Implant Flag | N |
| Date Removed | B |
| Device Sequence No | 1 |
| Device Event Key | 11518 |
| Manufacturer | DENTSPLY |
| Manufacturer Address | YORK PA 17405 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1994-02-07 |