MAUDE Adverse Event Report: O & M HALYARD, INC. HALYARD FLUIDSHIELD 3 N95; N95 MASK, SURGICAL

Medical Device Problem Code	Device Emits Odor (1425)
Health Effect - Clinical Codes	Asthma (1726); Respiratory Distress (2045); Burning Sensation (2146)
Type of Reportable Event	Malfunction
Event or Problem Description
Newly reprocessed n-95 halyard regular duckbill that has been aired for a week continues to smell of burnt plastic.When used, staff developed asthma exacerbation, difficulty of breathing, and causing nose/sinus burn sensation.Fda safety report id# (b)(4).

• Brand Name: HALYARD FLUIDSHIELD 3 N95
• Common Device Name: N95 MASK, SURGICAL
• Manufacturer (Section D): O & M HALYARD, INC.
• MDR Report Key: 10378719
• Report Number: MW5095935
• Device Sequence Number: 10581717
• Product Code: KHA
• Combination Product (Y/N): N
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Voluntary
• Type of Report: Initial
• Report Date (Section B): 08/05/2020

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
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 08/06/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 35 YR
• Patient Weight: 73