MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2009-03-18 for CREST ORAL DISCLOSING TABLETS manufactured by Young Dental Manufacturing.
[1061691]
My daughter received crest oral disclosing tablets from her school. No unique identifying logo on tablet face. No child resistant packaging. Is this product regulated? Could not find it listed in orange book. Is it even approved? Some tablet ingredients are listed by proprietary name -emdex, explotab, cherry flavor, d&c red 28 dye, magnesium stearate-. . . Those names would mean nothing to a lay person. Dye adheres to plaque on teeth as indicator of poor teeth brushing. Accompanying literature states "crest super tabs" yet product foil pouch is labeled crest non disclosing tablets. Not sure if these are technically considered a drug/diagnostic device?? I doubt it is a vitamin/food product. No one at the fda can answer my question. Fda suggested that i fill out a medwatch report. Literature states to use under supervision of adult yet product is targeted to children -1st grade- by crest and is packaged in non-cr packaging. Dose or amount: 1 tablet. Frequency: after brushing. Route: dental. Dates of use: 2009. Diagnosis or reason for use: to show areas of poor brushing. Event abated after use stopped or dose reduced: yes.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5010380 |
| MDR Report Key | 1346811 |
| Date Received | 2009-03-18 |
| Date of Report | 2009-03-18 |
| Date of Event | 2009-02-18 |
| Date Added to Maude | 2009-04-27 |
| 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 | 0 |
| Reporter Occupation | PATIENT |
| 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 | CREST ORAL DISCLOSING TABLETS |
| Generic Name | CREST SUPER TABS |
| Product Code | LFC |
| Date Received | 2009-03-18 |
| Lot Number | CT600 |
| ID Number | NONE ON TABLE |
| Device Expiration Date | 2009-09-30 |
| Device Availability | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | YOUNG DENTAL MANUFACTURING |
| Brand Name | CREST SUPER TABS |
| Generic Name | NONE |
| Product Code | LFC |
| Date Received | 2009-03-18 |
| Device Sequence No | 2 |
| Device Event Key | 0 |
| Manufacturer | YOUNG DENTAL MANUFACTURING |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2009-03-18 |