MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2011-03-25 for STIM-U-DENT STIM-U-DENTS 3436200001 manufactured by Revive Personal Products Company.
[1920850]
A product of review personal products company stim-u-dent plaque removers (mint flavor) has a disturbing taste, not a mint taste. I have used stim-u-dent for tens of years and have never experienced anything like this. This lot 1320c was made in (b)(4) and is packaged in a differently colored package. I contacted the manufacturer and they claim to know about, to be aware of quality issues, and said they would send me replacements. I am concerned as to what has been used to mfr this product. I have all but two "picks". I would be happy to send them to you.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5019971 |
| MDR Report Key | 2034787 |
| Date Received | 2011-03-25 |
| Date of Report | 2011-03-25 |
| Date Added to Maude | 2011-04-04 |
| 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 | STIM-U-DENT |
| Generic Name | DENTAL PICKS |
| Product Code | JET |
| Date Received | 2011-03-25 |
| Model Number | STIM-U-DENTS |
| Catalog Number | 3436200001 |
| Lot Number | 1320C |
| Operator | LAY USER/PATIENT |
| Device Availability | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | REVIVE PERSONAL PRODUCTS COMPANY |
| Manufacturer Address | MADISON NJ 07940 US 07940 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2011-03-25 |