MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2017-08-21 for MI PASTE, RECALDENT manufactured by Gc America.
[83220931]
I went to a new dentist (just moved from (b)(6)) for a regular cleaning. While there, they sold me mi paste, which they said would help my teeth be healthy. The box and the instructions (in many, many places) says that it is for professional use only. Not only that, it doesn't have anywhere on it how frequently to use it, and my hygienist said to use it daily. If this is for professional use only. It stands to reason it would only be used a person once every six months or so, but they told me every day. I'm scared being sold a product from my dentist that is clearly labeled to be for professional use only. I have zero dental training. "is the product over-the-counter: yes. " quantity: 1 40g tube. The problem did not stop the person reduced the dose or stopped taking or using the product.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5071688 |
| MDR Report Key | 6806772 |
| Date Received | 2017-08-21 |
| Date of Report | 2017-08-11 |
| Date of Event | 2017-08-07 |
| Date Added to Maude | 2017-08-21 |
| 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 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | MI PASTE, RECALDENT |
| Generic Name | MI PASTE, RECALDENT |
| Product Code | EJR |
| Date Received | 2017-08-21 |
| Device Availability | Y |
| Device Eval'ed by Mfgr | I |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | GC AMERICA |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2017-08-21 |