MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2019-02-14 for SNOW TEETH WHITENING SYSTEM NOT LISTED ON BOX NOT LISTED manufactured by Unknown.
[137260513]
I was given a gift called snow teeth whitening system. The box is stamped fda. The system includes an led light, whitening serum and sensitivity serum. With the system, there are a few basic instructions but i had to look up the snow web page to fully understand the instructions and found that the box instructions do not follow the online instructions completely. My concern is while they stamped fda on the box, why are there no ingredients listed for the liquid serums? After i used the product, the next day i was sick. I tried it again being very careful not to swallow any serum and again i was sick. I sent an email to (b)(4) requesting the ingredients but no response. The product is from the (b)(4). I also sent an email to their (b)(4) address and no response.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5084142 |
| MDR Report Key | 8343975 |
| Date Received | 2019-02-14 |
| Date of Report | 2019-01-31 |
| Date of Event | 2019-01-15 |
| Date Added to Maude | 2019-02-15 |
| 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 | SNOW TEETH WHITENING SYSTEM |
| Generic Name | HEAT SOURCE FOR BLEACHING TEETH |
| Product Code | EEG |
| Date Received | 2019-02-14 |
| Model Number | NOT LISTED ON BOX |
| Catalog Number | NOT LISTED |
| Lot Number | NOT LISTED |
| Operator | LAY USER/PATIENT |
| Device Availability | Y |
| Device Eval'ed by Mfgr | I |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | UNKNOWN |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2019-02-14 |