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

Device Problem Patient-Device Incompatibility (2682)

Patient Problems Headache (1880); Anxiety (2328)

Event Date 09/10/2020

Event Type  Injury  

Event Description

From wearing a face shield i got a severe headache and also cannot hear when wearing them.I also get anxiety when wearing anything covering my face.I don't take any prescriptions.Fda safety report id# (b)(4).

• Brand Name: FACE SHIELD
• Type of Device: ACCESSORY, SURGICAL APPAREL
• MDR Report Key: 10535423
• MDR Text Key: 207332187
• Report Number: MW5096642
• Device Sequence Number: 1
• 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: 09/11/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/14/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Was Device Available for Evaluation?: Yes
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 59 YR
• Patient Weight: 61