FDA Adverse Event
Summary report: N
N95 MASK
MDR report key: 11010617
·
Received December 11, 2020
Report
- Report Number
- MW5098352
- Date Received
- December 11, 2020
- Date of Event
- December 2, 2020
- Report Date
- December 11, 2020
- Manufacturer
- XIANTAO ZHONGYI SAFETY & PROTECTING PRODUCTS CO., LTD
- Product Code
- NZJ
- Report Source
- Voluntary report
- Reporter Location
- OR, US
- Reporter Occupation
- DENTAL HYGIENIST
Narratives
Description of Event or Problem · 1
A REPORTER STATED AN EMPLOYEE WHO WAS WEARING THE N95 MASK AT HER JOB ON DECEMBER 2 AND 3 WHEN SHE IS IN CONTACT OF PATIENTS IS HAVING SYMPTOMS SIMILAR TO COVID-19. REPORTER SAID THE EMPLOYEE HAS TAKEN THE TEST AND WAITING FOR THE RESULTS. REPORTER SAID THEY ARE NOT SURE IF THE EMPLOYEE'S SYMPTOMS ARE RELATED TO COVID-19 YET BUT THEY WANTED TO REPORT THE INCIDENT PER THE REQUIREMENTS.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1459394 | N95 MASK | RESPIRATOR, N95, FOR USE BY THE GENERAL PUBLIC IN PUBLIC HEALTH MEDICAL EMERGENC | NZJ | XIANTAO ZHONGYI SAFETY & PROTECTING PRODUCTS CO., LTD | ZYB-11 | ||
| 1459395 | N95 MASK | RESPIRATOR, N95, FOR USE BY THE GENERAL PUBLIC IN PUBLIC HEALTH MEDICAL EMERGENC | NZJ | XIANTAO ZHONGYI SAFETY & PROTECTING PRODUCTS CO., LTD | ZYB-11 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 22 YR |