MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 08 report with the FDA on 2009-08-12 for NATURAL ELEGANCE 9001004 manufactured by Confi-dental Products.
[1111290]
The distributor of natural elegance light cure pit and fissure sealant received the following report. Female pt hd a dental procedure performed in 2009 using light cure pit and fissure sealant. Pt stated a fluoride treatment was done as well. Pt stated product was put on dentin not on her tooth and now she is in severe pain in her tooth. Pt also complained of having changes in her estrogen levels causing pain and swelling in her mammary gland. Pt called this product an "estrogen disruptor". Pt stated she may have the tooth extracted today, but had specific questions about the product first. She asked if the product contains bisphenol a and stated she had the msds in hand. This report was forwarded to distributor's regulatory affairs (ra). Ra called the pt to find out the doctor and the product in question. The pt alleged that dr lee applied this product to her tooth on original date. Pt stated she was hospitalized for 3 days, given iv fluids and antibiotics but did state that the hospital claims that her condition is not related to the product that was placed on her tooth. No pain medication was given at the hospital. Pt then alleged that she saw a second dentist who placed a stainless steel cap over the tooth, and did not remove the product because it cannot be removed. Pt claims to have no known allergies to any chemicals and this dentist did not administer any pain medication. Ra left message for dr, but was unable to speak to the dr until thirteen days later. The dr provided the item number and lot number of the product in question. Dr stated that the pt returned to her office ten days after the original date, and she removed the light cure pit and fissure sealant and that there was no stainless steel cap on the tooth. The pt had dr show her all the material she had for a cap and wanted a cap with premise material. A temporary was placed on the tooth for the time being. Dr stated that she did not observe her to be in any pain. Dr was asked to return the syringe with the remaining pit and fissure sealant that was used on the pt. Rep at the manufacturer (confi-dental products) was notified before the actual item and lot number was known. The mfr was notified on 07-17-2009 via e-mail and an acknowledgement letter was sent on 07-20-2009. The syringe with the remaining product was received by the mfr on 07/22/2009.
Patient Sequence No: 1, Text Type: D, B5
[8293394]
The syringe with a little pit and fissure sealant material in it was returned for evaluation. An ir identification test was performed and showed that the material in the syringe met the specification for this material and no contaminates or unintended ingredients were found. Dr of a school of dentistry contacted another dr by phone on 08-11-2009. This material has been used in dentistry for many years and this is the first report of any problems of this type. The pt's alleged condition does not appear to be related to the use of this product.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1721729-2009-00002 |
| MDR Report Key | 1438835 |
| Report Source | 08 |
| Date Received | 2009-08-12 |
| Date of Report | 2009-06-23 |
| Date of Event | 2009-06-10 |
| Date Mfgr Received | 2009-07-17 |
| Device Manufacturer Date | 2008-06-01 |
| Date Added to Maude | 2009-08-18 |
| 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 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 0 |
| Event Location | 0 |
| Manufacturer Street | 416 S. TAYLOR AVE. |
| Manufacturer City | LOUISVILLE CO 80027 |
| Manufacturer Country | US |
| Manufacturer Postal | 80027 |
| Manufacturer Phone | 3036657535 |
| Single Use | 0 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | NATURAL ELEGANCE |
| Generic Name | DENTAL PIT AND FISSURE SEALANT |
| Product Code | EBC |
| Date Received | 2009-08-12 |
| Returned To Mfg | 2009-07-22 |
| Model Number | 9001004 |
| Lot Number | F8320-12 |
| Device Expiration Date | 2010-06-30 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | CONFI-DENTAL PRODUCTS |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Hospitalization | 2009-08-12 |