MAUDE Adverse Event Report: O&M HALYARD, INC. ANTI-FOG SURGICAL MASK, GREEN WITH FILM STRIP; ICP FACIAL PROTECTION PRODUCTS

Model Number	49235
Medical Device Problem Code	Component Incompatible (1108)
Health Effect - Clinical Code	No Code Available (3191)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The actual complaint product was not returned for evaluation.A review of the device history record is not possible as no lot number was provided.Root cause could not be determined.All information reasonably known as of (b)(6) 2019 has been included in this health authority report.Should additional information be obtained, a follow-up health authority report will be provided.The information provided by o&m halyard, inc.Represents all of the known information at this time.Despite good faith efforts to obtain additional information, the complainant / reporter was unable or unwilling to provide any further patient, product, or procedural details to o&m halyard, inc.O&m halyard, inc.Has no independent knowledge of the event reported but is relaying the information that was provided by the user facility where the incident occurred.This product incident is documented in the halyard health complaint database and identified as complaint (b)(4).This.
Event or Problem Description
During a retrospective review with the fda esg help desk it was determined that this complaint was sent to the test region and not the fda production region; therefore, this complaint is being submitted to the production region on (b)(6) 2019.It was allege by a doctor that the anti-fog green surgical masks are prone to condensation and drops into the surgical site.Additional information was requested but not received.

• Brand Name: ANTI-FOG SURGICAL MASK, GREEN WITH FILM STRIP
• Common Device Name: ICP FACIAL PROTECTION PRODUCTS
• Manufacturer (Section D): O&M HALYARD, INC.; 5405 windward parkway; alpharetta GA 30004
• MDR Report Key: 8787301
• Report Number: 9616096-2019-00004
• Device Sequence Number: 19249620
• Product Code: FXX
• UDI-Device Identifier: 30680651492358
• UDI-Public: 30680651492358
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K823078
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 03/14/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Model Number: 49235
• Device Catalogue Number: 991049235
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 03/14/2019
• Initial Report FDA Received Date: 07/12/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other