MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2009-08-11 for MINT FLAVORED STIM-U-DENT manufactured by Johnson & Johnson.
[18617186]
Hello, i am reporting a problem with johnson & johnson mint flavored stimudents. They are toothpicks. I noticed a burning sensation in my mouth and throat after using this last batch i bought. The package says they are made in a foreign country, and i am concerned that there are some odd chemical in this product that would be causing this. It has caused me a great deal of pain and discomfort. Dose or amount: toothpick. Frequency: 1x day. Route: po. Dates of use: 2009. Event abated after use stopped or dose reduced: yes. Diagnosis or reason for use: gum disease prevention. Event reappeared after reintroduction: yes.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5012402 |
| MDR Report Key | 1440973 |
| Date Received | 2009-08-11 |
| Date of Report | 2009-08-11 |
| Date of Event | 2009-08-11 |
| Date Added to Maude | 2009-08-24 |
| 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 | MINT FLAVORED STIM-U-DENT |
| Generic Name | 25 PACKS |
| Product Code | JET |
| Date Received | 2009-08-11 |
| Device Availability | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | JOHNSON & JOHNSON |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2009-08-11 |