MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2019-02-19 for ORAL B manufactured by Procter & Gamble (manufacturing) Ireland Ltd..
[137257058]
A study shows procter and gamble? S oral b glide dental floss may contain pfas. [https://www. Nature. Com/articles/s41370-018-0109-y]. I have quite a few containers of this floss. Procter and gamble needs to replace them with dental floss that is safe. (b)(4).
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5084161 |
| MDR Report Key | 8358842 |
| Date Received | 2019-02-19 |
| Date of Report | 2019-02-19 |
| Date of Event | 2019-01-16 |
| 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 | 0 |
| Product Problem Flag | 0 |
| 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 | ORAL B |
| Generic Name | FLOSS, DENTAL |
| Product Code | JES |
| Date Received | 2019-02-19 |
| Device Availability | Y |
| Device Eval'ed by Mfgr | I |
| Device Sequence No | 0 |
| Device Event Key | 0 |
| Manufacturer | PROCTER & GAMBLE (MANUFACTURING) IRELAND LTD. |
| Brand Name | ORAL B |
| Generic Name | FLOSS, DENTAL |
| Product Code | JES |
| Date Received | 2019-02-19 |
| Device Availability | Y |
| Device Eval'ed by Mfgr | I |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | PROCTER & GAMBLE CO., REGULATORY AFFAIRS |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2019-02-19 |