MAUDE Adverse Event Report: O&M HALYARD, INC. FLUIDSHIELD* 1 PROCEDURE MASK WITH SO SOFT* LINING AND SO SOFT* EARLOOPS, YELLOW; FLUIDSHIELD* LEVEL 1 PROCEDURE MASK

Model Number	25867
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
Event or Problem Description
Patient 1 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 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.
Additional Manufacturer Narrative
Representative product sample was returned to the failure analysis lab for evaluation.The samples were evaluated under ambient light conditions and appeared intact.There are no sharp edges or corners observed on the masks.There are no loose fibers observed on the masks.The samples were inspected and measured by comparing both to specification component.The samples were found to be assembled according to the specification drawing.Device history record (dhr) evaluation was performed for the product code 25867 and lot number am1310061 identified in the complaint.A quality nonconformance was not reported at the time of production.Based on the low to negligible health hazard presented by the components of the level 1 mask in combination with user exposures of less than twenty-four (24) hours and acceptable biocompatibility results, the level 1 masks have a wide margin-of-safety for users when worn as indicated.Manufacturing conducts visual and functional inspection of each device throughout production.According to manufacturing records, the device was manufactured per procedures and specifications, then released by quality assurance.All information reasonably known as of october 13, 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 1 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: 15211364
• Report Number: 9616096-2022-00005
• Device Sequence Number: 4622672
• Product Code: FXX
• UDI-Device Identifier: 30680651258671
• UDI-Public: 30680651258671
• Combination Product (Y/N): N
• Initial Reporter State: WI
• Initial Reporter Country: US
• PMA/510(K) Number: K110455
• 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): 09/26/2022

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 Model Number: 25867
• Device Catalogue Number: 991025867
• 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: 09/26/2022
• Initial Report FDA Received Date: 08/11/2022
• Supplement Report FDA Received Date: 10/25/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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