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