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	Compatibility Problem (2960)
Health Effect - Clinical Code	Local Reaction (2035)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The product involved in the event reported is available for evaluation.We are awaiting receipt of sample from the reporter.Upon conclusions of the complaint investigation a follow up report will be submitted.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
The customer reported that a few employees were having allergic reactions that caused wounds on the face while wearing the mask.
Additional Manufacturer Narrative
The samples were evaluated under ambient light conditions.The mask was found to be assembled according to the specification drawing for lot number am0343431.Each mask was opened fully and inspected on the inside and the outside.There are no defects observed on any of the samples.The failure analysis lab was not able to evaluate or confirm the root cause for the reaction experienced by the customer.A device history records (dhr) evaluation was performed for the code 48100 identified in the complaint.According to the documented records, the product was manufactured according to the approved manufacturing procedures and specifications.The product was released by quality assurance.A quality nonconformance was not reported during production.Manufacturing conducts visual and functional inspections of each device throughout production aside from the qa inspection.Notification was sent to manufacturing leaders for awareness.There was no complaint trend for the code 48100.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 21 cfr 803, and should not be considered to be an admission that an o&m halyard, inc.Product is defective or has caused serious injury.

• 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; ciudad de acuna coahuila, mexico 26220 ; MX 26220
• Manufacturer Contact: nichole early ; o&m halyard, inc.; 1 edison drive; alpharetta, GA 30005 ; 8287820529
• MDR Report Key: 16701812
• Report Number: 9616096-2023-00001
• Device Sequence Number: 14371883
• Product Code: FXX
• UDI-Device Identifier: 30680651481000
• UDI-Public: 30680651481000
• Combination Product (Y/N): N
• Initial Reporter Country: NL
• PMA/510(K) Number: K823078
• 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): 05/25/2023

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: 991048100
• Device Lot Number: AM0343431
• 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: 03/08/2023
• Supplement Date Received by Manufacturer: 05/01/2023
• Initial Report FDA Received Date: 04/07/2023
• Supplement Report FDA Received Date: 05/31/2023
• 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