FDA Adverse Event
Injury
Summary report: N
CLOTH MASK
MDR report key: 11607700
·
Received April 1, 2021
Report
- Report Number
- MW5100498
- Event Type
- Injury
- Date Received
- April 1, 2021
- Date of Event
- March 19, 2021
- Report Date
- March 30, 2021
- Manufacturer
- UNK
- Product Code
- QKR
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Voluntary report
- Reporter Location
- NE, US
- Reporter Occupation
- PATIENT
Narratives
Description of Event or Problem · 1
IT HAPPENED THIS DAY, BUT IT HAS HAPPENED MANY TIMES IN THE LAST YEAR. EVERY TIME I WEAR A CLOTH MASK, I GET A SORE THROAT. IT WILL LAST A FEW DAYS. I ALWAYS WEAR THEM ONCE AND I ALWAYS WASH THEM AFTER EACH USE. IT'S NOT LIFE THREATENING, BUT IT DOES WORRY ME. COMPANY: VARIOUS. FDA SAFETY REPORT ID# (B)(4).
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 501263 | CLOTH MASK | FACE MASK PER ENFORCEMENT POLICY FOR FACE MASKS AND RESPIRATORS DURING THE COVID | QKR | UNK |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 50 YR | Disability |