FDA Adverse Event
Summary report: N
FFP2 NR MASK
MDR report key: 9952866
·
Received April 10, 2020
Report
- Report Number
- MW5094103
- Date Received
- April 10, 2020
- Date of Event
- April 3, 2020
- Report Date
- April 9, 2020
- Manufacturer
- JIANGXI BEI HUAN INDUSTRY CO., LTD
- Product Code
- FXX
- Report Source
- Voluntary report
- Reporter Location
- US
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
Narratives
Description of Event or Problem · 1
THE COMPANY THAT I WORK FOR RECEIVED SEVERAL HUNDRED MASKS PRESUMING THAT THEY WERE AUTHORIZED FFP2 MASKS FROM A (B)(4) MANUFACTURER. THE MASKS BEGAN TO FALL APART AND STRAPS WERE BREAKING ON MANY MASKS. UPON CLOSER INSPECTION, THE MASKS ARE NOT LABELED WITH ANY APPROPRIATE MARKINGS AND THE MANUFACTURER IS NOT LISTED IN APPENDIX A OF THE EUA NOR ARE THEY REGISTERED ON THE FDA DATABASE. THE MANUFACTURER IS JIANGXI BEI HUAN INDUSTRY CO., LTD. FDA SAFETY REPORT ID# (B)(4).
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 411233 | FFP2 NR MASK | MASK, SURGICAL | FXX | JIANGXI BEI HUAN INDUSTRY CO., LTD |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Other |