MAUDE Adverse Event Report: OWENS & MINOR HALYARD INC. ANTI-FOG SURGICAL MASK GREEN 50; ICP FACIAL PROTECTION

Model Number	49235
Medical Device Problem Code	Compatibility Problem (2960)
Health Effect - Clinical Code	Local Reaction (2035)
Date of Event	10/11/2021
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported by the surgeon was using the agreed upon green mask from halyard today and his loupes kept fogging up.This is a critical safety issue as being in the middle of a procedure and not being able to see could be catastrophic to the patient.I know that we seem to have adapted to the halyard mask, but i am now hearing that there have been issues.The ones with the plastic on the outside tend to accumulate moisture from the rebreathing and this develops to the point that it drips onto the field.This residue causes breakouts and rashes on staff.
Additional Manufacturer Narrative
The product involved in the report was not returned for evaluation.It was reported by the surgeon who was using the agreed upon green mask from halyard today and his loupes kept fogging up.This is a critical safety issue as being in the middle of a procedure and not being able to see could be catastrophic to the patient.I know that we seem to have adapted to the halyard mask, but i am now hearing that there have been issues.The ones with the plastic on the outside tend to accumulate moisture from the rebreathing and this develops to the point that it drips onto the field.No other treatment was noted.This residue causes breakouts and rashes on staff.All information reasonably known as of 08nov2021 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.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 o&m halyard, inc.Complaint database and identified as complaint (b)(4).
Additional Manufacturer Narrative
O&m halyard, inc.Received a complaint related to halyard* anti-fog surgical mask, product code 49235 on (b)(6), 2021.A surgeon reported that his loops kept fogging up during a procedure and accumulated moisture dripped onto the surgical site.The product involved in the report was not returned for evaluation and no lot number was provided.Since no lot number was provided, a process and materials investigation were conducted for the most recent lot produced for product code 49235 and no assignable root cause was identified.Records demonstrate that the product is manufactured according to the specification.The incoming inspection process includes an assessment of the polyethylene anti fog material and film polyethylene material.The materials are analyzed according to the incoming inspection requirements which require a certificate of conformance.In addition, a quality non-conformance record was initiated to review the design and dimensional characteristics of the mask to determine if the design may have contributed to the user experience.The fmea in the risk management file identifies fogging and condensation as an improbable occurrence with a low risk level.This is consistent with the results of the complaint trend for product code 49235 and failure mode condensation.All information reasonably known as of 14dec2021 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 o&m halyard, inc.Complaint database and identified as complaint (b)(4).This information is submitted pursuant to 21cfr803, in compliance with the medical device reporting requirement and should not be considered an admission that an o&m halyard, inc.Product is defective or caused serious injury.H3 other text : device not returned.

• Brand Name: ANTI-FOG SURGICAL MASK GREEN 50
• Common Device Name: ICP FACIAL PROTECTION
• Manufacturer (Section D): OWENS & MINOR HALYARD INC.; 1 edison drive; alpharetta GA 30005
• Manufacturer (Section G): LA ADA DE ACUNA KM; 4.5 carretera presa la amist; cuidad de acuna
• Manufacturer Contact: keisha weaver ; 1 edison drive; alpharetta, GA 30005 ; 4704485396
• MDR Report Key: 12774785
• Report Number: 9616096-2021-00002
• Device Sequence Number: 5589108
• Product Code: FXX
• UDI-Device Identifier: 30680651492358
• UDI-Public: 30680651492358
• Combination Product (Y/N): N
• Initial Reporter State: MI
• Initial Reporter Country: US
• PMA/510(K) Number: K823078
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 12/03/2021

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: Health Professional
• Device Model Number: 49235
• Device Catalogue Number: 991049235
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/11/2021
• Supplement Date Received by Manufacturer: 12/03/2021
• Initial Report FDA Received Date: 11/08/2021
• Supplement Report FDA Received Date: 12/14/2021
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown