MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05 report with the FDA on 2014-12-31 for IPS CERAMIC ETCHING GEL 531548 manufactured by Ivoclar Vivadent Ag.
[5262255]
The material bust out of the bottle when it was opened splashing into the eye of the dental assistant and onto the furniture. The assistant went to the er and was released. It was reported that there was no permanent damage.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 9612352-2014-00004 |
| MDR Report Key | 4381585 |
| Report Source | 05 |
| Date Received | 2014-12-31 |
| Date of Report | 2014-12-30 |
| Date of Event | 2014-10-10 |
| Date Mfgr Received | 2014-10-10 |
| Date Added to Maude | 2015-01-09 |
| 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 | MS DANNA HARTNETT |
| Manufacturer Street | 175 PINEVIEW DR |
| Manufacturer City | AMHERST NY 14228 |
| Manufacturer Country | US |
| Manufacturer Postal | 14228 |
| Manufacturer Phone | 7166910010 |
| Manufacturer G1 | IVOCLAR VIVADENT AG |
| Manufacturer Street | BENDERERSTRASSE 2 |
| Manufacturer City | SCHAAN FL-9494 |
| Manufacturer Country | LS |
| Manufacturer Postal Code | FL-9494 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | IPS CERAMIC ETCHING GEL |
| Generic Name | CERAMIC ETCHING GEL |
| Product Code | ELL |
| Date Received | 2014-12-31 |
| Catalog Number | 531548 |
| Lot Number | T19195 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | N |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | IVOCLAR VIVADENT AG |
| Manufacturer Address | BENDERERSTRASSE 2 SCHAAN FL-9494 LS FL-9494 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2014-12-31 |