FDA Adverse Event
Injury
Summary report: N
FACE MASK
MDR report key: 11854714
·
Received May 19, 2021
Report
- Report Number
- MW5101432
- Event Type
- Injury
- Date Received
- May 19, 2021
- Report Date
- May 18, 2021
- Manufacturer
- UNK
- Product Code
- QKR
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Voluntary report
- Reporter Occupation
- PATIENT FAMILY MEMBER OR FRIEND
Narratives
Description of Event or Problem · 1
MY DAUGHTER IS MADE TO WEAR A MASK AT SCHOOL. SHE COMES HOME WITH A SORE THROAT, SHORTNESS OF BREATH, ANXIETY, AND FACIAL DERMATITIS. PLEASE REVOKE THE EUA ON ALL MASKS FOR THE PUBLIC. THEY ARE HARMING EVERYONE. FDA SAFETY REPORT ID # (B)(4).
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 742847 | FACE MASK | FACE MASK PER ENFORCEMENT POLICY FOR FACE MASKS AND RESPIRATORS DURING THE COVID | QKR | UNK |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 8 YR | Disability |