MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2011-08-02 for ULTRADENT ULTRASEAL manufactured by Ultradent Products, Inc..
[1994213]
I purchased dental sealants for both my children with the expectation that they would prevent decay. For my children, the opposite result occurred. Recent x-rays revealed multiple cavities under three of my daughter's sealants, and singular cavities under four of my sons. My daughter is (b)(6) and my son is (b)(6). Neither have cavities elsewhere. My children have received consistent dental care. My daughter's sealants were applied in 2000 and 2004. Frequency: 8. Dates of use: (b)(6) 2000 - (b)(6) 2006.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5021619 |
| MDR Report Key | 2195361 |
| Date Received | 2011-08-02 |
| Date of Report | 2011-08-02 |
| Date of Event | 2000-06-09 |
| Date Added to Maude | 2011-08-15 |
| Event Key | 0 |
| Report Source Code | Voluntary report |
| Manufacturer Link | N |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Reporter Occupation | PATIENT FAMILY MEMBER OR FRIEND |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 0 |
| Event Location | 0 |
| Single Use | 0 |
| Previous Use Code | 0 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | ULTRADENT ULTRASEAL |
| Generic Name | DENTAL SEALANT |
| Product Code | EBC |
| Date Received | 2011-08-02 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | ULTRADENT PRODUCTS, INC. |
| Manufacturer Address | 505 W. 10200 S. SOUTH JORDAN UT 84095 US 84095 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2011-08-02 |