MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2020-03-18 for DISPOSABLE PARTICLE RESPIRATOR FACE MASK COATED IN TEA TREE OR ALOE VERA ESSENTI manufactured by Unknown.
[184516496]
(b)(6) online selling disposable particle respirator face mask coated in tea tree or aloe vera essential oil. This product did not get registered with fda, the company was not registered for selling this kind of medical product. The products actually are regular face masks from (b)(6), to sell them at high prices during outbreak of covid-19, the company claims coated with tea tree or aloe vera essential oil. This is misleading. (b)(6) was warned by fda and ftc previously. This company keeps doing the same bad things. (b)(6) inc. Fda safety report id# (b)(4).
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5093843 |
| MDR Report Key | 9853384 |
| Date Received | 2020-03-18 |
| Date of Report | 2020-03-15 |
| Date of Event | 2020-03-15 |
| Date Added to Maude | 2020-03-19 |
| 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 | 3 |
| Brand Name | DISPOSABLE PARTICLE RESPIRATOR FACE MASK COATED IN TEA TREE OR ALOE VERA ESSENTI |
| Generic Name | MASK, OXYGEN |
| Product Code | BYG |
| Date Received | 2020-03-18 |
| Device Availability | N |
| Device Eval'ed by Mfgr | I |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | UNKNOWN |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2020-03-18 |