MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional report with the FDA on 2018-01-15 for POWDER PORCELAIN 406 manufactured by Ultradent Products.
[97291826]
Refiling due to original report not being sucessfully uploaded to data base
Patient Sequence No: 1, Text Type: N, H10
[97291827]
Dental assistant pushed the plunger of the porcelain etch and it appered to be clogged. She then pushed harder. No porcelain etch came out the syringe. When she went to remove the tip, the pressure she had created let of couple of drops of the product come out of the syringe and landed in her eye. She claims to have had safety glasses on. She immediately flushed her eye with water and sought medical attention at the local hospital. At the hospital , they put saline in her eye followed by an antiboitic. She was given some ointment which she believes to be more antibiotic. Her vision was slightly blurred. She said that her eye was tearing alot. She went to the hospital 5 days later for a check up and her vision was fine. She still had some soreness when she moves her eye. The hospital told her that was normal. They expected it to go away, we suggested that she get wrap around safety glass and not to apply excessive pressure on a plunger if a tip appears to be clogged. A follow up phone call confirmed that she was fine and had no further problems.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1718912-2017-00036 |
| MDR Report Key | 7191422 |
| Report Source | HEALTH PROFESSIONAL |
| Date Received | 2018-01-15 |
| Date of Report | 2017-12-19 |
| Date of Event | 2014-04-10 |
| Date Mfgr Received | 2014-01-10 |
| Device Manufacturer Date | 2013-10-01 |
| Date Added to Maude | 2018-01-15 |
| 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 | 3 |
| Event Location | 3 |
| 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 | 8015525512 |
| Manufacturer G1 | ULTRADENT PRODUCT INC |
| 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 | POWDER PORCELAIN |
| Generic Name | PORCELAIN ETCH |
| Product Code | EIH |
| Date Received | 2018-01-15 |
| Model Number | 406 |
| Catalog Number | 406 |
| Lot Number | B8VYL |
| Device Expiration Date | 2014-05-15 |
| Operator | DENTAL ASSISTANT |
| Device Availability | N |
| 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 | 2018-01-15 |