MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 04,05,06 report with the FDA on 2012-02-29 for ULTRACAL XS 5117 manufactured by Ultradent Products, Inc..
[2630397]
Spoke with (b)(6). She said that a patient got calcium hydroxide in their eye. The eye was painful and started to swell. They had flushed the eye thoroughly with water.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1718912-2012-00002 |
| MDR Report Key | 2483294 |
| Report Source | 04,05,06 |
| Date Received | 2012-02-29 |
| Date of Report | 2012-02-27 |
| Date of Event | 2012-02-07 |
| Date Mfgr Received | 2012-02-07 |
| Device Manufacturer Date | 2005-04-01 |
| Date Added to Maude | 2012-07-31 |
| 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 | OTHER HEALTH CARE PROFESSIONAL |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 0 |
| Event Location | 0 |
| Manufacturer Street | 10200 S 505 W |
| Manufacturer City | SOUTH JORDAN UT 84095 |
| Manufacturer Country | US |
| Manufacturer Postal | 84095 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | ULTRACAL XS |
| Generic Name | CALCIUM HYDROXIDE CAVITY LINER |
| Product Code | EJK |
| Date Received | 2012-02-29 |
| Model Number | 5117 |
| Catalog Number | 5117 |
| Lot Number | B0BRX |
| Device Expiration Date | 2007-04-30 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | ULTRADENT PRODUCTS, INC. |
| Manufacturer Address | SOUTH JORDAN UT US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Hospitalization | 2012-02-29 |