MAUDE Adverse Event Report: CLEAR FACE SHIELD; ACCESSORY, SURGICAL APPAREL

Device Problem Insufficient Information (3190)

Patient Problems Dyspnea (1816); Headache (1880); Nausea (1970); Dizziness (2194); Confusion/ Disorientation (2553)

Event Date 03/16/2021

Event Type  Injury  

Event Description

Due to a state mask mandate, my employer requires me to wear a facemask and a face shield while working.After wearing a mask and/or shield for five minutes, sometimes less, i feel as if it is harder to breathe and i'm not getting enough oxygen.The longer i wear it/them, the worse the feeling gets, and i end up getting a headache within 20 minutes, which continues until i can remove the mask/shield and sometimes for hours after.I have also experienced nausea and lightheadedness and slower thinking on previous occasions when i have had to wear a mask/shield.This has been going on since (b)(6) 2020.Requires sufficient oxygen rather than carbon dioxide in inhaled air.Fda safety report id # (b)(4).

• Brand Name: CLEAR FACE SHIELD
• Type of Device: ACCESSORY, SURGICAL APPAREL
• MDR Report Key: 11541756
• MDR Text Key: 241924250
• Report Number: MW5100159
• Device Sequence Number: 2
• Product Code: LYU
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Patient
• Type of Report: Initial
• Report Date: 03/17/2021
• 2 Devices were Involved in the Event: 1 2

1 Patient was Involved in the Event

• Date FDA Received: 03/19/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Disability
• Patient Age: 63 YR
• Patient Weight: 54