MAUDE Adverse Event Report: O&M HALYARD, INC FACEMASK,PROCEDURE,YELLOW,50; ICP FACIAL PROTECTION PRODUCTS

Model Number	25867
Medical Device Problem Code	Compatibility Problem (2960)
Health Effect - Clinical Code	Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581)
Type of Reportable Event	Serious Injury
Event or Problem Description
Complainant stated that she had a mask shaped rash on her face for four days after using the mask and complained of an odor from the box that has since dissipated.There was "black spots" on some masks, breathing difficulties with the mask and a feeling of inhaling particulates.
Additional Manufacturer Narrative
The product involved in the event was returned for evaluation.The dispenser box was inspected.There are no visual damages on the dispenser box.The samples were removed from the dispenser box and placed on the table for inspection.There are no visual damages observed on the inside or the outside of any of the eleven masks.There are no unusual folds or sharp edges.The ear loops appear securely attached.The failure analysis lab is unable to confirm the incident of reaction experienced by the customer with the evaluation conducted in the lab.A follow-up report will be provided upon conclusion of remaining investigation activities.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
One (1) dispenser box containing eleven (11) unused samples was received in the product packaging.There were no visual damages observed on the inside or the outside of any of the eleven masks.There were no unusual folds or sharp edges.The ear loops appear securely attached.Device history record (dhr) evaluation was performed for the product code identified in the complaint.According to the documented records, the product was manufactured according to approved specifications.A quality nonconformance was not reported at the time of production.Manufacturing conducts visual and functional inspections of product during manufacture.As part of the cleaning activities at the manufacturing facility, the surfaces are cleaned with 70% ipa minimally once per shift.Requirements are established to enter manufacturing areas, including clothing restrictions, hair net use, hand washing and the use of sanitizing gel.According to the calendar for equipment maintenance, pm (preventive maintenance) is completed every nine weeks on the machine.Based on evaluation of the biocompatibility data and risk management file, the potential human health hazard presented is low to negligible.A trending analysis was performed, there is no upward trend for the past 12 months for this type of incident.Notification was sent to manufacturing leaders for awareness.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 an o&m halyard, inc.Product is defective or has caused serious injury.

• Brand Name: FACEMASK,PROCEDURE,YELLOW,50
• Common Device Name: ICP FACIAL PROTECTION PRODUCTS
• 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: 18812854
• Report Number: 9616096-2024-00001
• Device Sequence Number: 4342528
• Product Code: FXX
• UDI-Device Identifier: 30680651258671
• UDI-Public: 30680651258671
• Combination Product (Y/N): N
• Initial Reporter State: NY
• 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): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 04/29/2024

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: AM3239081
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/13/2024
• 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: Not provided
• Supplement Date Received by Manufacturer: 04/16/2024
• Initial Report FDA Received Date: 02/29/2024
• Supplement Report FDA Received Date: 04/29/2024
• 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: Other
• Patient Sex: Unknown