FDA Adverse Event
Injury
Summary report: N
N-95
MDR report key: 10541765
·
Received September 15, 2020
Report
- Report Number
- MW5096682
- Event Type
- Injury
- Date Received
- September 15, 2020
- Date of Event
- August 10, 2020
- Report Date
- September 12, 2020
- Manufacturer
- UNK
- Product Code
- NZJ
- Product Problem
- Yes
- Report Source
- Voluntary report
- Reporter Location
- GA, US
- Reporter Occupation
- PATIENT
Narratives
Description of Event or Problem · 1
DUE TO A MASK USE AND MANDATE. I HAD SEVERE HEADACHES, LOW OXYGEN SATURATIONS, LIGHT HEADED/DIZZINESS. AS I HAVE LATER FOUND OUT THAT A MASK MANDATE IS NOT A WRITTEN LAW, YET THIS HAS OVER THE COURSE OF FIVE MONTHS CAUSED ME GREAT DISTRESS WITH MY HEALTH. FDA SAFETY REPORT ID# (B)(4).
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 999835 | N-95 | RESPIRATOR, N95, FOR USE BY THE GENERAL PUBLIC IN PUBLIC HEALTH MEDICAL EMERGENC | NZJ | UNK |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 58 YR | Disability |