MAUDE Adverse Event Report: O&M HALYARD, INC. N95 PARTICULATE FILTER RESPIRATOR AND SURGICAL MASK; ICP FACIAL PROTECTION PRODUCTS

Model Number	46727
Medical Device Problem Code	Component Incompatible (1108)
Health Effect - Clinical Code	Local Reaction (2035)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The product involved in the event was not available for return.A follow-up report will be provided upon conclusion of investigation.This information is submitted pursuant to 21cfr803, and should not be considered to be an admission that an o&m halyard, inc.Product is defective or has caused serious injury.This product incident is documented in the o&m halyard, inc.Complaint database and identified as complaint (b)(4).
Event or Problem Description
An anonymous amazon review was received which indicates while wearing the mask, the customer got styes on two separate occasions.Additional questions were requested from amazon (the customer), no response has been received to-date.
Additional Manufacturer Narrative
The product involved in the event was not available for return.Attempts were made to acquire additional information from amazon regarding the incident, however the reviewer's post did not provide any contact information and was posted anonymously; therefore, investigation and additional incident details were limited.No lot number was provided; therefore, a dhr review was not possible.No samples were available so an evaluation was not possible.A 12 month trend review for the product code was conducted.There were no similar instances where mask use caused a stye.This incident appears isolated.The manufacturing site performs monthly trending analysis and will continue to monitor for any corrective action needs.This information is submitted pursuant to 21cfr803, and should not be considered to be an admission that an o&m halyard, inc.Product is defective or has caused serious injury.This product incident is documented in the o&m halyard, inc.Complaint database and identified as complaint: (b)(4).H3 other text: device not returned.

• Brand Name: N95 PARTICULATE FILTER RESPIRATOR AND SURGICAL MASK
• 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 ACUNA; km 4.5 carreterra presa; la amistad; ciudad de acuna, coahuila, mexico 26220 ; MX 26220
• Manufacturer Contact: nichole early ; 1 edison drive; alpharetta, GA 30005 ; 8287820529
• MDR Report Key: 18314266
• Report Number: 9616096-2023-00087
• Device Sequence Number: 17838597
• Product Code: MSH
• UDI-Device Identifier: 30680651467271
• UDI-Public: 30680651467271
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K974068
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Consumer
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 01/22/2024

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: Lay User/Patient
• Device Model Number: 46727
• Device Catalogue Number: 991046727
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/13/2023
• Supplement Date Received by Manufacturer: 01/11/2024
• Initial Report FDA Received Date: 12/12/2023
• Supplement Report FDA Received Date: 01/24/2024
• 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