MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2016-12-19 for ENAMELAST manufactured by Ultradent.
[62939132]
I took my daughter for a dental check-up and fluoride treatment was applied on her teeth. She complained of stomach pain shortly after the visit, was nauseous and vomited within the next two hours after the appointment. Remained nauseous for the rest of the day and evening. Fluoride poisoning. Did the poisoning stop after the person reduced the dose or stopped taking or using the product: yes. Routine fluoride treatment. Do you still have the product in case we need to evaluate it: no.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5066806 |
| MDR Report Key | 6188811 |
| Date Received | 2016-12-19 |
| Date of Report | 2016-11-02 |
| Date of Event | 2016-10-20 |
| Date Added to Maude | 2016-12-20 |
| 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 | 3 |
| Event Location | 3 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | ENAMELAST |
| Generic Name | ENAMELAST |
| Product Code | LBH |
| Date Received | 2016-12-19 |
| Device Availability | N |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | ULTRADENT |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 5 | 1. Other | 2016-12-19 |