MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,06 report with the FDA on 2013-04-01 for VISCOSTAT CLEAR 6408 manufactured by Ultradent Products.
[20232798]
When the dental assistant was filling up a 1. 2 syringe with the 30ml, she took off the 1. 2 syringe and a small amount of viscostat flow up under her safety glasses into her eye. She flushed her eye for 5-10 minutes. Corner of her eye was a little white. The assistant is fine now. It was suggested that they used safety glasses that wrap around to avoid any possibility of this happening in the future.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1718912-2013-00001 |
| MDR Report Key | 3032585 |
| Report Source | 05,06 |
| Date Received | 2013-04-01 |
| Date of Report | 2013-03-01 |
| Date of Event | 2013-02-12 |
| Date Mfgr Received | 2013-02-12 |
| Device Manufacturer Date | 2012-11-01 |
| Date Added to Maude | 2014-08-18 |
| 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 | MRS. RONA MURPHY |
| Manufacturer Street | 505 WEST 10200 SOUTH |
| Manufacturer City | SOUTH JORDAN UT 84095 |
| Manufacturer Country | US |
| Manufacturer Postal | 84095 |
| Manufacturer Phone | 8015535512 |
| Manufacturer G1 | ULTRADENT PRODUCTS |
| Manufacturer Street | 505 WEST 10200 SOUTH |
| Manufacturer City | SOUTH JORDAN UT 84095 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 84095 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | VISCOSTAT CLEAR |
| Generic Name | TISSUE MANAGEMENT |
| Product Code | MVL |
| Date Received | 2013-04-01 |
| Model Number | 6408 |
| Catalog Number | 6408 |
| Lot Number | B7NG3 |
| Device Expiration Date | 2016-04-30 |
| Operator | OTHER |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | N |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | ULTRADENT PRODUCTS |
| Manufacturer Address | 505 WEST 10200 SOUTH SOUTH JORDAN UT 84095 US 84095 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2013-04-01 |