MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2019-02-19 for REACH WAXED, UNFLAVORED WAXED FLOSS 30024909 manufactured by Johnson & Johnson Consumer Inc..
[137400161]
I purchased new dental floss at a (b)(6) location. I have not had to buy a new supply for years. This supply has a bad taste. I am pretty sure the taste is not because of my oral hygiene. I regularly floss and have been doing so for many years. I have never experience a taste like this. I will probably ask for a refund but don? T want to not say something in the chance the public is at risk. Questions? (b)(4): outside u. S, dial collect (b)(4). Purchase date: (b)(6) 2019. (b)(4).
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5084160 |
| MDR Report Key | 8358831 |
| Date Received | 2019-02-19 |
| Date of Report | 2019-02-19 |
| Date of Event | 2019-02-06 |
| Date Added to Maude | 2019-02-21 |
| 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 | REACH WAXED, UNFLAVORED WAXED FLOSS |
| Generic Name | FLOSS, DENTAL |
| Product Code | JES |
| Date Received | 2019-02-19 |
| Model Number | 30024909 |
| Lot Number | 32018D |
| Device Availability | Y |
| Device Eval'ed by Mfgr | I |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | JOHNSON & JOHNSON CONSUMER INC. |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2019-02-19 |