MAUDE Adverse Event Report: O&M HALYARD, INC. FLUIDSHIELD* 3 FOG-FREE PROCEDURE MASK WITH SO SOFT* LINING AND SO SOFT* EARLOOP; FLUIDSHIELD* LEVEL 3 FOG-FREE PROCEDURE MASK

Model Number	47107
Medical Device Problem Code	Component Incompatible (1108)
Health Effect - Clinical Code	Local Reaction (2035)
Date of Event	03/26/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The product involved in the event reported has not been returned but a representative sample is anticipated.A follow-up report will be provided upon the conclusion of the investigation.All information reasonably known as of august 11, 2022 has been included in this medical device report.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).This information is submitted pursuant to 21cfr803, in compliance with the medical device reporting requirement and should not be considered to be an admission that a o&m halyard, inc.Product is defective or has caused serious injury.
Event or Problem Description
Patient 3 of 4.Employee experienced reactions on four occasions associated with mask use.The reaction(s) consistent of tongue feeling thick with itchy throat.Initial reaction occurred on (b)(6) 2022 and subsequently on (b)(6) 2022, (b)(6) 2022 to (b)(6) 2022 and (b)(6) 2022 to (b)(6) 2022.Employee health prescribed intramuscular epinephrine, intravenous prednisone, benadryl, pepcid, solumedrol, and hydroxyzine.The employee followed up with an allergist and had two patch tests of steroids.Employee was referred to pulmonologist and rheumatologist.She currently continues benadryl, pepcid, solumedrol, hydroxyzine, 20 mg prednisone, allegra (twice a day), and zyrtec (twice a day) by mouth.
Additional Manufacturer Narrative
The representative product sample was returned to the failure analysis lab for evaluation.A representative sample was received for this complaint and evaluated by the failure analysis lab.The sample was evaluated under ambient light conditions.The visor of the sample arrived with creases and nicks.The visor appears worn and handled.The mask does not exhibit any sharp edges.The mask does not exhibit any loose fibers.The mask was found to be assembled according to the specification drawing.While the mask exhibits some signs of wear, as received in the lab, the failure analysis lab is unable to confirm the complaint of "reaction" experienced by the customer with the evaluation conducted in the lab.The device history records (dhr) evaluation was performed for the code 47107 and lot number am0285111 identified in the complaint.According to the documented records, the product was manufacturing according to the approved manufacturing procedures, specifications and then released by quality assurance.A quality nonconformance was not reported at the time of production.All information reasonably known as of september 26, 2022 has been included in this medical device report.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).This information is submitted pursuant to 21cfr803, in compliance with the medical device reporting requirement and should not be considered to be an admission that a o&m halyard, inc.Product is defective or has caused serious injury.

• Common Device Name: FLUIDSHIELD* LEVEL 3 FOG-FREE PROCEDURE MASK
• Manufacturer (Section D): O&M HALYARD, INC.; 1 edison drive; alpharetta GA 30005
• Manufacturer (Section G): LA ADA DE ACUÑA; km 4.5 carreterra presa; la amistad; cd. acuña, coahuila mexico 26220 ; MX 26220
• Manufacturer Contact: nichole early ; 1 edison drive; alpharetta, GA 30005 ; 8287820529
• MDR Report Key: 15211103
• Report Number: 9616096-2022-00003
• Device Sequence Number: 4622666
• Product Code: FXX
• UDI-Device Identifier: 30680651471070
• UDI-Public: 30680651471070
• Combination Product (Y/N): N
• Initial Reporter State: WI
• Initial Reporter Country: US
• PMA/510(K) Number: K131879
• 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: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 09/02/2022

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 Expiration Date: 10/11/2025
• Device Model Number: 47107
• Device Catalogue Number: 991047107
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• 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: 07/13/2022
• Supplement Date Received by Manufacturer: 09/02/2022
• Initial Report FDA Received Date: 08/11/2022
• Supplement Report FDA Received Date: 09/29/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/11/2020
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Female