MAUDE Adverse Event Report: O&M HALYARD, INC. THE LITE ONE SURGICAL MASK, BLUE; ICP FACIAL PROTECTION PRODUCTS

Model Number	48100
Medical Device Problem Code	Component Incompatible (1108)
Health Effect - Clinical Code	Hypersensitivity/Allergic reaction (1907)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The product involved in this complaint is available but has not been received yet.A follow-up report will be provided upon conclusion of the investigation.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
Incident one.Customer advised they have had two reactions.The mask was worn for ten minutes prior to face feeling hot and itchy, then red.The reaction continues to worsen even after the mask is removed.Face and eyes show some swelling.Customer has indicated the initial reaction occurred in 2021.They switched to a hypoallergenic mask following reaction.Only recently she was out of this alternate mask, and reverted to the 48100 at which time she had this recent reaction.Prescribed medication: steroid cream, steroid antiinflammation meds, medicated eye drops, and use of over-the-counter meds like benadryl.After a week, the symptoms still remained.The medication has cleared about 80% of the issue.
Additional Manufacturer Narrative
Customer indicated a sample was available; however, sample was not returned following three requests to complaint reporter to do so.A device history record (dhr) evaluation was performed for product lot identified in the complaint.According to the documented records, the product was manufactured according to the approved manufacturing procedures and met specifications for final quality assurance release.A quality nonconformance was not reported during production.Manufacturing conducts visual and functional inspections throughout production according to sampling plan using the ansi/asqz 1.4 to release the product.Visual inspection is performed based on aql 1.0 level s-4.As part of cleaning activities at the manufacturing facility, the surfaces are cleaned with 70% ipa minimally once per-shift.Procedures define requirements to enter manufacturing areas including clothing restrictions, usage of hair covering, handwashing and sanitizing gel use.The face mask has been tested according to iso 10993-1 and has passed biocompatibility tests.Complaint trend analysis was performed for code 48100 for the past 12 months from april 2024 to april 2025.There is no upward trend for this issue during this review time period.Notification was sent to manufacturing leaders for awareness.This product incident is documented in the o&m halyard, inc.Complaint database and is 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.

• Brand Name: THE LITE ONE SURGICAL MASK, BLUE
• Common Device Name: ICP FACIAL PROTECTION PRODUCTS
• Manufacturer (Section D): O&M HALYARD, INC.; 1220 old alpharetta rd; ste 320; alpharetta GA 30005
• Manufacturer (Section G): LA ADA DE ACUNA; km 4.5 carreterra presa la amistad; ciudad de acuna; coahuila, mexico
• Manufacturer Contact: nichole coggins ; 1220 old alpharetta rd; ste 320; alpharetta, GA 30005 ; 8287820529
• MDR Report Key: 22076892
• Report Number: 9616096-2025-00007
• Device Sequence Number: 9394269
• Product Code: FXX
• UDI-Device Identifier: 30680651481000
• UDI-Public: 30680651481000
• Combination Product (Y/N): N
• Initial Reporter State: MT
• Initial Reporter Country: US
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 07/08/2025

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: 48100
• Device Catalogue Number: 48100
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Yes
• 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: 05/16/2025
• Supplement Date Received by Manufacturer: 07/04/2025
• Initial Report FDA Received Date: 05/23/2025
• Supplement Report FDA Received Date: 07/08/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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