MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2020-03-06 for FLUGUARD DISPOSABLE FACE MASK WITH ELASTIC EAR LOOP 3 PLY 100 manufactured by Unk.
[183329093]
(b)(6) ,listed 400-ply masks on (b)(6), claiming they are effective for blocking pollen, dust, germs, etc. I purchased the masks and sent them to (b)(6) as personal protection items for a friend. When received, the masks were defective due to lack of the middle filter layer and cannot block any of the particles it claimed. Seller refused to take defective product back. Fda safety report id# (b)(4).
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5093621 |
| MDR Report Key | 9805375 |
| Date Received | 2020-03-06 |
| Date of Report | 2020-03-05 |
| Date of Event | 2020-02-27 |
| Date Added to Maude | 2020-03-09 |
| 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 FAMILY MEMBER OR FRIEND |
| 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 | FLUGUARD DISPOSABLE FACE MASK WITH ELASTIC EAR LOOP |
| Generic Name | MASK, SURGICAL |
| Product Code | FXX |
| Date Received | 2020-03-06 |
| Model Number | 3 PLY 100 |
| Device Availability | Y |
| Device Eval'ed by Mfgr | I |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | UNK |
| Manufacturer Address | UNK UNK |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2020-03-06 |