FDA Adverse Event
Injury
Summary report: N
CLOTH FACE MASK
MDR report key: 11744632
·
Received April 28, 2021
Report
- Report Number
- MW5101075
- Event Type
- Injury
- Date Received
- April 28, 2021
- Date of Event
- April 23, 2021
- Report Date
- April 27, 2021
- Manufacturer
- UNK
- Product Code
- QKR
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Voluntary report
- Reporter Occupation
- PATIENT
Narratives
Description of Event or Problem · 1
EXPERIENCED SEVERE HEADACHE WHICH LED TO MIGRAINE AFTER WEARING A MASK FOR 30 MINUTES. FDA SAFETY REPORT ID # (B)(4).
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 638590 | CLOTH FACE MASK | FACE MASK PER ENFORCEMENT POLICY FOR FACE MASKS AND RESPIRATORS DURING THE COVID | QKR | UNK |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 27 YR |