MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05 report with the FDA on 2011-09-12 for OPAL SEAL 500061 manufactured by Ultradent Products, Inc..
[20950765]
Doctor was pressing the plungers on opal seal with a new tip and the fibers shot out and opal seal ended up on the doctor's face and in his eye. He rinsed his eye, but was going to head over to an eye doctor for further advice. Directed to the msds for instructions to rinse eye.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1718912-2011-00004 |
| MDR Report Key | 2255248 |
| Report Source | 05 |
| Date Received | 2011-09-12 |
| Date of Report | 2011-09-09 |
| Date of Event | 2011-08-17 |
| Date Mfgr Received | 2011-08-17 |
| Device Manufacturer Date | 2011-06-01 |
| Date Added to Maude | 2012-06-28 |
| 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 Street | 505 WEST 10200 SOUTH |
| Manufacturer City | SOUTH JORDAN UT 84095 |
| Manufacturer Country | US |
| Manufacturer Postal | 84095 |
| Manufacturer Phone | 8015534200 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | OPAL SEAL |
| Generic Name | NONE |
| Product Code | DYH |
| Date Received | 2011-09-12 |
| Model Number | 500061 |
| Catalog Number | 500061 |
| Lot Number | B6723 |
| Device Expiration Date | 2012-09-30 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | ULTRADENT PRODUCTS, INC. |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Hospitalization | 2011-09-12 |