MAUDE Adverse Event Report: OM HALYARD, INC. HALYARD; MASK, SURGICAL

Model Number	46828
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	09/11/2020
Type of Reportable Event	Malfunction
Event or Problem Description
5-10 n95 duckbill masks elastic broke when putting mask on.Halyard fluidsheild n95 particulate filter respirator (b)(4).

• Brand Name: HALYARD
• Common Device Name: MASK, SURGICAL
• Manufacturer (Section D): OM HALYARD, INC.; 9120 lockwood blvd; mechanicsville VA 23116
• MDR Report Key: 10592478
• Report Number: 10592478
• Device Sequence Number: 17218877
• Product Code: FXX
• Combination Product (Y/N): N
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: User Facility
• Type of Report: Initial
• Report Date (Section B): 09/24/2020
• Report Date (Section F): 09/24/2020

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: Health Professional
• Device Model Number: 46828
• Device Catalogue Number: 46828
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Event Location: Hospital
• Date Report to Manufacturer: 09/28/2020
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 09/28/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Date Report Sent to FDA: 09/24/2020