MAUDE Adverse Event Report: BYD PRECISION MANUFACTURE CO., LTD. BYD CARE DE2322 NIOSH N95 PARTICULATE RESPIRATOR; RESPIRATOR, SURGICAL

Model Number	TC-84A-9221
Health Effect - Clinical Code	Corneal Abrasion (1789)
Date of Event	09/11/2021
Type of Reportable Event	Malfunction
Event or Problem Description
Rn reported that as she was placing a byd n95 face mask, the strap on one side disconnected from the mask and struck her left eye causing a corneal abrasion injury.

• Brand Name: BYD CARE DE2322 NIOSH N95 PARTICULATE RESPIRATOR
• Common Device Name: RESPIRATOR, SURGICAL
• Manufacturer (Section D): BYD PRECISION MANUFACTURE CO., LTD.; 4455 eastgate mall suite 200; san diego CA 92121
• MDR Report Key: 12511954
• Report Number: 12511954
• Device Sequence Number: 16844283
• Product Code: MSH
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: User Facility
• Initial Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date (Section B): 09/21/2021
• Report Date (Section F): 09/21/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: No Information
• Device Model Number: TC-84A-9221
• Device Catalogue Number: DE2322
• Device Lot Number: 6200731
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report to Manufacturer: 09/22/2021
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 09/22/2021
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Date Report Sent to FDA: 09/21/2021